FDA Device Recall Z-0016-2022: Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0016-2022.

Recall Res Number

Z-0016-2022

Recalling Firm / Manufacturer

Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel

FEI Number

3009161350

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2021-07-26

Date Posted

N/A

Date Terminated

2023-09-21

Product Code

NDP

Event Number

88576

Product Quantity

Product Description Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

Reason for Recall Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.

Action Details Impacted customers were contacted on July 26, 2021 via overnight delivery of written notification. The firm is replacing all components listed in the recall, purchased prior to 7/21/2021. Customers were asked to complete and return the provided product replacement form. A customer service representative will contact you to evaluate your inventory and to facilitate the exchange immediately. Please contact your Customer Service Department at 866-902-9272 for any questions.

Distribution Pattern US Nationwide distribution. No foreign distribution from US.

Code Information / Serial Numbers All lots manufactured prior to July 21, 2021.

Related Establishments / Registrations

ZimVie Canada Inc. Registration: 1000244346 View Registration
DREVE DENTAMID GMBH Registration: 1000486347 View Registration
BRASSELER U.S.A. DENTAL, LLC Registration: 1032227 View Registration
Sterigenics U.S., LLC Registration: 1036836 View Registration
ZimVie US Corp LLC Registration: 1038806 View Registration
WHIP-MIX CORP. Registration: 1043617 View Registration
PRACTICON, INC. Registration: 1051614 View Registration
Sterigenics U.S. LLC Registration: 1054811 View Registration
SUNCOAST DENTAL, INC. Registration: 1054986 View Registration
KLS-Martin L.P. Registration: 1057946 View Registration
BIOHORIZONS IMPLANT SYSTEMS INC. Registration: 1060818 View Registration
SALVIN DENTAL SPECIALTIES, LLC Registration: 1066741 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
DENTSPLY IH Inc. Registration: 1222802 View Registration
Primo Medical Group, INC Registration: 1222928 View Registration
BICON, LLC Registration: 1223843 View Registration
NSK AMERICA CORP. Registration: 1422375 View Registration
Cislak Manufacturing, Inc. Registration: 1422507 View Registration
Sterigenics US LLC Registration: 1423662 View Registration
Isomedix Operations, Inc. Registration: 1424263 View Registration
PRIME DENTAL MANUFACTURING, INC. Registration: 1424442 View Registration
ACCUMEDIX, INC. Registration: 1424785 View Registration
Sterigenics US, LLC Registration: 1526534 View Registration
TROY INNOVATIVE INSTRUMENTS, INC. Registration: 1530530 View Registration
OCO BIOMEDICAL Registration: 1627417 View Registration
RMO Registration: 1718476 View Registration
Basic Dental Implant Systems, Inc. Registration: 1723412 View Registration
ORCHID UNIQUE Registration: 1828288 View Registration
PARAGON MEDICAL, INC. Registration: 1834331 View Registration
The Belport Company, Inc DBA Gingi-Pak Registration: 2014676 View Registration
ZEST ANCHORS, LLC Registration: 2023950 View Registration
Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration
NOBEL BIOCARE USA, LLC Registration: 2027971 View Registration
ARCH Medical Solutions - Escondido LLC Registration: 2029005 View Registration
Sterigenics U.S., LLC Registration: 2029275 View Registration
H & H CO. Registration: 2085199 View Registration
PAC-DENT INC. Registration: 2086043 View Registration
EMERY ENTERPRISES INC. Registration: 2086964 View Registration
ARCH MEDICAL& AEROSPACE- MINNEAPOLIS, LLC Registration: 2133778 View Registration
J & J INSTRUMENTS, LLC Registration: 2246990 View Registration
TITAN IMPLANTS, INC. Registration: 2249649 View Registration
Keystone Industries Registration: 2280629 View Registration
COLTENE/WHALEDENT INC. Registration: 2416455 View Registration
Sklar Corporation Registration: 2431166 View Registration
DENTATUS USA LTD. Registration: 2435118 View Registration
Keystone Industries Registration: 2523320 View Registration
AMERICAN DENTAL IMPLANT CORPORATION Registration: 2523430 View Registration
A. TITAN INSTRUMENTS, INC. Registration: 2531684 View Registration
PREAT Corporation Registration: 2918719 View Registration
Sterngold Dental LLC Registration: 2921595 View Registration
APPLIED DENTAL INC. DBA AD Surgical Registration: 2954705 View Registration
LISI MEDICAL Remmele Registration: 3000203391 View Registration
SWEDEN & MARTINA S.P.A. Registration: 3001082453 View Registration
Theia Holding SA Registration: 3001110146 View Registration
LABORATORIOS DENTALES DE ZONA FRANCA, S.A. Registration: 3001295407 View Registration
LEONE SPA Registration: 3001561923 View Registration
IMPLANT DIRECT SYBRON MANUFACTURING LLC Registration: 3001617766 View Registration
DRAKE PRECISION DENTAL LABORATORY, INC. Registration: 3002706372 View Registration
DELTAMED GMBH Registration: 3002789526 View Registration
Synergy Health Sterilisation UK Ltd Registration: 3002807310 View Registration
GREEN DENTAL LAB Registration: 3002916277 View Registration
THOMMEN MEDICAL, AG Registration: 3003184527 View Registration
Ivoclar Vivadent Manufacturing GmbH Registration: 3003310824 View Registration
OSSTEM IMPLANT CO., LTD. Registration: 3003394081 View Registration
SOUTHERN IMPLANTS (PTY) LTD Registration: 3003394627 View Registration
BLUE SKY BIO, LLC Registration: 3003402534 View Registration
VERICOM CO., LTD. Registration: 3003449480 View Registration
QUALITY TECH SERVICES, LLC Registration: 3003477135 View Registration
GHOUSIA AMANAT SURGICAL Registration: 3003700106 View Registration
Cybermed Inc. Registration: 3003781339 View Registration
NEW STETIC Registration: 3003794907 View Registration
ELOS MEDTECH TIMMERSDALA AB Registration: 3003847101 View Registration
ZAIN'S MEDICAL IMAGE Registration: 3003877407 View Registration
B. ALI IMPEX Registration: 3003882387 View Registration
RELIABLE DENTAL STUDIO, INC. Registration: 3003893092 View Registration
MECTRON S.P.A. Registration: 3003933619 View Registration
PDT, INC. Registration: 3003963832 View Registration
INNOVATION MEDITECH GMBH Registration: 3004003391 View Registration
DENTAL CRAFTERS Registration: 3004036186 View Registration
JEIL MEDICAL CORPORATION Registration: 3004049923 View Registration
NOBIL-METAL S P A Registration: 3004149679 View Registration
S.I.N. Implant System Ltda Registration: 3004201263 View Registration
MIS Implants Technologies Ltd. Registration: 3004203816 View Registration
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. Registration: 3004417597 View Registration
SIC INVENT AG Registration: 3004443656 View Registration
NEW PERFECT DENTAL LAB Registration: 3004556094 View Registration
DENTIUM CO., LTD. Registration: 3004578807 View Registration
PURACON GMBH Registration: 3004638532 View Registration
RELIABLE DENTAL STUDIO, INC. Registration: 3004726107 View Registration
NEOBIOTECH CO., LTD. Registration: 3004730368 View Registration
ALBENSI DENTAL LAB Registration: 3004755100 View Registration
DENTSPLY SIRONA INC Registration: 3004884150 View Registration
DAVIS DENTAL LAB Registration: 3004935484 View Registration
Ivoclar Vivadent GmbH Registration: 3004966444 View Registration
NOBEL BIOCARE PROCERA, LLC Registration: 3005031178 View Registration
COWELLMEDI CO., LTD. Registration: 3005115116 View Registration
FORUM ENGINEERING TECHNOLOGIES (96) LTD. Registration: 3005164841 View Registration
PARAGON IMPLANT MFG., LLC Registration: 3005409899 View Registration
MICRO PRECISION SWISS Registration: 3005497913 View Registration
BIOMATERIALS KOREA INC. Registration: 3005515228 View Registration
Megagen Implant Co., Ltd. Registration: 3005554774 View Registration
DEVEMED GMBH Registration: 3005621335 View Registration
PREVEST DENPRO LIMITED Registration: 3005628474 View Registration
A.B. DENTAL DEVICES LTD Registration: 3005663340 View Registration
ANMUTH MEDICAL INTERNATIONAL LLC Registration: 3005695838 View Registration
B&L BIOTECH CO., INC Registration: 3005831677 View Registration
ZIRKONZAHN SRL Registration: 3005904906 View Registration
GoldenDent Registration: 3005972890 View Registration
EMERALD INSTRUMENTS Registration: 3005973280 View Registration
ANDREAS HETTICH GMBH Registration: 3005990076 View Registration
CSM Implant Registration: 3005998060 View Registration
BBF STERILISATIONSSERVICE GMBH Registration: 3006017180 View Registration
SICAT GMBH & CO. KG Registration: 3006098230 View Registration
COHO Advanced Materials Tech. Co., Ltd. Registration: 3006110126 View Registration
DDS DENTALAB Registration: 3006191485 View Registration
GENOSS Co., Ltd. Registration: 3006223010 View Registration
ZimVie Spain S.L.U. Registration: 3006411780 View Registration
NATURAL ESTHETICS Registration: 3006523393 View Registration
NOBEL BIOCARE DISTRIBUTION CENTER BV Registration: 3006540014 View Registration
Evidence Implant Inc. Registration: 3006592743 View Registration
ZEST ANCHORS, LLC Registration: 3006796211 View Registration
Yamahachi Dental Material (Changshu) Co., Ltd. Registration: 3006942327 View Registration
Shinhung MST Co., Ltd. Registration: 3006948193 View Registration
Z-SYSTEMS AG Registration: 3006948427 View Registration
Universal Orthodontic Lab, Inc. Registration: 3007010296 View Registration
DENTIS CO., LTD. Registration: 3007031098 View Registration
DIO Corporation Registration: 3007126709 View Registration
HIOSSEN INC. Registration: 3007135442 View Registration
IDS KOREA Registration: 3007160911 View Registration
SMILE LINE SA Registration: 3007167099 View Registration
Straumann Villeret SA Registration: 3007218081 View Registration
DREVE AMERICA CORP. Registration: 3007277229 View Registration
W&H IMPEX INC. Registration: 3007279848 View Registration
CAMLOG Biotechnologies GmbH Registration: 3007283751 View Registration
DENTSPLY Implants N.V. Registration: 3007362683 View Registration
F. M. HOWELL & CO. Registration: 3007366413 View Registration
EUROFINS INPAC MEDIZINTECHNIK GMBH Registration: 3007515069 View Registration
ADIN DENTAL IMPLANT SYSTEMS LTD. Registration: 3007518363 View Registration
EUROTEKNIKA Registration: 3007521935 View Registration
ARDS Industries Ltd Registration: 3007529467 View Registration
HOSPIMED MFG Registration: 3007587775 View Registration
MEDIMECCA CO LTD Registration: 3007649394 View Registration
ELOS MEDTECH PINOL A/S Registration: 3007689689 View Registration
MICROWARE PRECISION CO., LTD. Registration: 3007738812 View Registration
CORTEX DENTAL IMPLANTS INDUSTRIES LTD. Registration: 3007842672 View Registration
US ORTHODONTIC PRODUCTS Registration: 3008005217 View Registration
F-SIX DENTAL TECHNOLOGY CO.,LIMITED Registration: 3008081327 View Registration
BIODENTA SWISS AG Registration: 3008088588 View Registration
5 AXIS DENTAL INC. Registration: 3008184555 View Registration
BEGO IMPLANT SYSTEMS GMBH & CO. KG Registration: 3008252251 View Registration
JJGC Industria e Comercio de Materiais Dentarios SA Registration: 3008261720 View Registration
ANATOMAGE, INC. Registration: 3008272529 View Registration
INNOBIOSURG CO., LTD. Registration: 3008309654 View Registration
BEST VALUE CERAMICS INC Registration: 3008317118 View Registration
Shandong Huge Dental Material Corporation Registration: 3008320092 View Registration
PSM Medical GmbH Registration: 3008323540 View Registration
Dental Direkt GmbH Registration: 3008347275 View Registration
CeramTec Schweiz GmbH Registration: 3008388248 View Registration
MCTBIO Registration: 3008388427 View Registration
RODO Digital Prosthetics Registration: 3008409772 View Registration
AMEDCON MEDICAL TECHNOLOGY (SHENZHEN) CO., LTD. Registration: 3008493350 View Registration
OT MEDICAL GMBH Registration: 3008496301 View Registration
TALLADIUM ESPANA, SL Registration: 3008517893 View Registration
NICHROMINOX Registration: 3008519369 View Registration
SYMMETRY MEDICAL POLYVAC SAS Registration: 3008534770 View Registration
Nobel Biocare Services AG Registration: 3008693672 View Registration
XIAMEN YIZHOU IMP. & EXP. CO., LTD. Registration: 3008763803 View Registration
MEDENTIKA GMBH Registration: 3008770646 View Registration
AVINENT IMPLANT SYSTEM S.L.U. Registration: 3008791019 View Registration
LX PRECISION SHANGHAI CO LTD Registration: 3008791302 View Registration
SAMAPLAST AG Registration: 3008793310 View Registration
COSMETIC INTERNATIONAL LIMITED Registration: 3008799812 View Registration
SURGICRAFTS Registration: 3008808049 View Registration
CERAROOT S.L. Registration: 3008808095 View Registration
Swann-Morton(Services) Limited Registration: 3008812251 View Registration
Implant Logistics / AMS Micromedical Registration: 3008870565 View Registration
Park Dental Research Corp Registration: 3008910197 View Registration
Zfx GmbH Registration: 3008932779 View Registration
KJ MEDITECH CO., LTD. Registration: 3008959419 View Registration
VICO DENTAL TECHNOLOGY CO. LTD Registration: 3009011536 View Registration
Olulo LLC Registration: 3009049852 View Registration
Guangzhou Four E's Scientific Co., Ltd. Registration: 3009155756 View Registration
PALTOP ADVANCED DENTAL SOLUTIONS LTD Registration: 3009161350 View Registration
DENTIMED SAO JOAO Registration: 3009171220 View Registration
PRECISION ONE MEDICAL Registration: 3009201148 View Registration
LIBRAL TRADERS PVT. LTD. Registration: 3009268271 View Registration
ALLIANCE GLOBAL TECHNOLOGY CO., LTD. Registration: 3009325911 View Registration
PANORAMA INTERNATIONAL. Registration: 3009340886 View Registration
HUANGHUA PROMISEE DENTAL CO., LTD Registration: 3009420946 View Registration
KTJ Medical Technology Co.,Ltd. Registration: 3009482100 View Registration
AIDITE (QINHUANGDAO) TECHNOLOGY CO., LTD Registration: 3009482106 View Registration
IVOCLAR VIVADENT, INC. Registration: 3009496224 View Registration
WARANTEC Co., Ltd. Registration: 3009514134 View Registration
Ritter Implants GmbH & Co. KG Registration: 3009528809 View Registration
SURGIDENT CO., LTD. Registration: 3009551666 View Registration
BIOTEM CO., LTD. Registration: 3009611645 View Registration
Wellspect Healthcare Registration: 3009632672 View Registration
KTJ DENTAL LAB COMPANY LIMITED Registration: 3009687180 View Registration
IMAGINE MILLING TECHNOLOGIES, LLC Registration: 3009727738 View Registration
DENTIN IMPLANTS TECHNOLOGIES LTD. Registration: 3009737865 View Registration
RODO MEDICAL, INC Registration: 3009742323 View Registration
CARMEX - PRECISION TOOLS LTD. Registration: 3009747037 View Registration
HUNG CHUN BIO-S CO., LTD. Registration: 3009761487 View Registration
PANTHERA DENTAL INC Registration: 3009779268 View Registration
DENTONA AG Registration: 3009815428 View Registration
GMI DENTAL IMPLANTOLOGY, S.L. Registration: 3009847764 View Registration
ACH Medical Co., Ltd. Registration: 3009848796 View Registration
Keystone Industries - Gibbstown Registration: 3010002722 View Registration
Modern Dental International Trading Limited Registration: 3010022489 View Registration
NDX nSequence Registration: 3010138699 View Registration
DOF INC Registration: 3010158379 View Registration
Synergy Health Allershausen GmbH Registration: 3010160527 View Registration
Shining 3D Tech Co.,Ltd. Registration: 3010173003 View Registration
MAQUIRA INDUSTRIA DE PRODUTOS ODONTOLOGICOS Registration: 3010245461 View Registration
ZUGA MEDICAL, INC. Registration: 3010251542 View Registration
Formlabs Inc. Registration: 3010279788 View Registration
Synergy Sterilisation South Africa Proprietary Ltd Registration: 3010287685 View Registration
BAECHLER FEINTECH AG Registration: 3010287737 View Registration
DENTA CRAFT INSTRUMENTS Registration: 3010288346 View Registration
TRI Dental Implants Direct GmbH Registration: 3010303805 View Registration
DENTAL WINGS GMBH Registration: 3010377510 View Registration
Aragogamma, S.L. Registration: 3010392243 View Registration
BHI Implants Registration: 3010393542 View Registration
RAY CO., LTD, Registration: 3010445368 View Registration
JINTAIK (Yunnan) BIOTECH CO., LTD. Registration: 3010453282 View Registration
CURITIBA ESTERILIZACAO DE MATERIAIS MEDICOS LTDA Registration: 3010596333 View Registration
IQ IMPLANTS LTD Registration: 3010610960 View Registration
KAISER PRECISION CO. Registration: 3010654657 View Registration
HANGZHOU WESTLAKE BIOMATERIAL CO., LTD. Registration: 3010669020 View Registration
Biotech Dental Registration: 3010730876 View Registration
ADVANTECH PLASTICS, LLC Registration: 3010852338 View Registration
WHITECAP DENTAL LAB AND MILLING, LLC Registration: 3010860907 View Registration
ATRIA Co. Registration: 3010896988 View Registration
DITRON DENTAL LTD Registration: 3010948854 View Registration
MEDEQUIP IMPLANT SUPPLIES Registration: 3011103459 View Registration
VERSAH LLC Registration: 3011117802 View Registration
DIGITAL DENTAL DEPOT Registration: 3011170140 View Registration
INTAI TECHNOLOGY CORP. IMPLANTS BUSINESS UNIT Registration: 3011187779 View Registration
CDM CENTER OF EXCELLENCE LTD. Registration: 3011210208 View Registration
GUILIN YIKESHI Medical Device CO LTD Registration: 3011215096 View Registration
etkon GMBH Registration: 3011221537 View Registration
SWEDEN & MARTINA INC Registration: 3011276344 View Registration
W&H DENTALWERK BUERMOOS GMBH - SITE 2 Registration: 3011300255 View Registration
NORIS MEDICAL LTD. Registration: 3011390931 View Registration
3D DIAGNOSTIX INC Registration: 3011429437 View Registration
RAY AMERICA INC Registration: 3011471624 View Registration
HEFEI MLUSH SANITARY PRODUCTS CO.,LTD Registration: 3011526299 View Registration
HANGZHOU ANGSHENG ORTHODONTIC PRODUCTS CO., LTD Registration: 3011539071 View Registration
S.G.S. INTERNATIONAL LTD Registration: 3011545243 View Registration
SHENZHEN DENCO MEDICAL CO., LTD. Registration: 3011554142 View Registration
D.A.N.D METAL INDUSTRIES NORTH LTD Registration: 3011587630 View Registration
PRISMATIK DENTALCRAFT, INC. Registration: 3011649314 View Registration
NOVA IMPLANTS LTD Registration: 3011808221 View Registration
DENTSPLY IH BV Registration: 3011824442 View Registration
POINTIMPLANT Co., Ltd Registration: 3011891801 View Registration
Keystone Dental Inc. Registration: 3011936113 View Registration
TRI DENTAL IMPLANTS INT. AG Registration: 3012172055 View Registration
DIGITAL DENTAL DEPOT LIMITED Registration: 3012341864 View Registration
ENVISIONTEC GMBH Registration: 3012389497 View Registration
BOMEI CO., LTD. Registration: 3012396434 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
TruAbutment Korea Co., Ltd. Registration: 3012422333 View Registration
TRUABUTMENT INC. Registration: 3012422693 View Registration
BIO CONCEPT CO., LTD. Registration: 3012465917 View Registration
Kerr Corporation Registration: 3012477813 View Registration
VULCAN CUSTOM DENTAL Registration: 3012481042 View Registration
SANICURE BV Registration: 3012494290 View Registration
HI MEDICAL CO., LTD. Registration: 3012502601 View Registration
HUMEDITECH CO., LTD Registration: 3012564447 View Registration
DMG DIGITAL ENTERPRISES SE Registration: 3012623144 View Registration
HONGKONG DS DENTAL TECHNOLOGY CO. LIMITED Registration: 3012821743 View Registration
35NEWTONS, LLC Registration: 3012930250 View Registration
SUPERIOR MACHINED PRODUCTS, INC. Registration: 3013034344 View Registration
CHENGDU BESMILE MEDICAL TECHNOLOGY CO., LTD. Registration: 3013102320 View Registration
Dentsply Implants Manufacturing GmbH Registration: 3013111692 View Registration
BLZ TECHNOLOGY (WUHAN) CO., LTD. Registration: 3013137141 View Registration
ZHUHAI DS DENTAL TECHNOLOGY CO., LTD Registration: 3013156109 View Registration
MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD. Registration: 3013167159 View Registration
SURGIKOR, LLC Registration: 3013173272 View Registration
J DENTAL CARE SRL Registration: 3013264549 View Registration
SEWON MEDIX, INC. Registration: 3013271380 View Registration
VEENAK INTERNATIONAL LIMITED Registration: 3013298431 View Registration
ELEGANT DIRECT CORP Registration: 3013465593 View Registration
SCULPTURE STUDIOS Registration: 3013479553 View Registration
SHANDONG ZHUSHI PHARMACEUTICAL GROUP CO., LTD Registration: 3013496867 View Registration
JIANGYIN NANQUAN MACROMOLECULE PRODUCT CO., LTD. Registration: 3013506123 View Registration
Ormco Corporation Registration: 3013508670 View Registration
PART PRECISION SWEDEN AB Registration: 3013527433 View Registration
DENTAL STUDIO Registration: 3013547731 View Registration
ZIACOM IMPLANTS SLU Registration: 3013547803 View Registration
The Argen Corporation Registration: 3013551048 View Registration
MEDICLUS CO., LTD Registration: 3013584861 View Registration
IDOC DENTAL LAB Registration: 3013934196 View Registration
NEXTCON INTERNATIONAL Registration: 3013946322 View Registration
Modern Dental Laboratory (DG) Co., Ltd. Registration: 3013950969 View Registration
TERRATS MEDICAL, S.L. Registration: 3014118611 View Registration
REX IMPLANTS, INC Registration: 3014174860 View Registration
IMPROVE CO.,LIMITED Registration: 3014253211 View Registration
M/S LEIXIR RESOURCES PVT. LTD Registration: 3014270094 View Registration
SPRINTRAY INC. Registration: 3014289665 View Registration
BIOTECH DENTAL SAS Registration: 3014290448 View Registration
BIOLINE DENTAL IMPLANT SYSTEMS LTD Registration: 3014329459 View Registration
DMS CO., LTD. Registration: 3014330970 View Registration
SDS SWISS DENTAL SOLUTIONS Registration: 3014540272 View Registration
JMU DENTAL, INC Registration: 3014683120 View Registration
ENLIGHTEN MATERIALS CO., LTD. Registration: 3014778017 View Registration
VP INNOVATO HOLDINGS LTD Registration: 3014837662 View Registration
PRO3DURE MEDICAL GMBH Registration: 3014888923 View Registration
UNIQA DENTAL LTD Registration: 3014938434 View Registration
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD. Registration: 3014953747 View Registration
SKY DENTAL LAB (International) Registration: 3015044778 View Registration
SHENZHEN ROGIN MEDICAL CO., LTD Registration: 3015136927 View Registration
NORTHWELL HEALTH Registration: 3015146876 View Registration
CPM PRECISION GMBH Registration: 3015160953 View Registration
3DIEMME SRL Registration: 3015173183 View Registration
DTI IMPLANT SYSTEMS Registration: 3015218457 View Registration
Ormco Corporation Registration: 3015272949 View Registration
Graphy Inc. Registration: 3015302693 View Registration
ALPHA DENT IMPLANTS GMBH Registration: 3015383403 View Registration
Formlabs Ohio, Inc. Registration: 3015491441 View Registration
iBrite Suzhou Technology Co., Ltd Registration: 3015491448 View Registration
SMART DENTURE CONVERSIONS, LLC Registration: 3015527825 View Registration
FOO TIAN DENTAL LABORATORY Registration: 3015531834 View Registration
Changsha Easyinsmile Intelligence Technology Co.Ltd. Registration: 3015548849 View Registration
GUANGZHOU HEYGEARS IMC.INC Registration: 3015674635 View Registration
Modern Dental Global Solutions Limited Registration: 3015674959 View Registration
IMPLACIL DE BORTOLI MATERIAL ODONTOLOGICO LTDA Registration: 3015775866 View Registration
Sklar Corporation - Warehouse Registration: 3015895045 View Registration
IDITEC NORTH WEST S.L. Registration: 3015914458 View Registration
PIC DENTAL LLC Registration: 3015915424 View Registration
ARUM DENTISTRY Co., Ltd. Registration: 3015978392 View Registration
STRATASYS LTD Registration: 3016074824 View Registration
DENTALINE LLC Registration: 3016172557 View Registration
DSI DENTAL SOLUTIONS LTD Registration: 3016447764 View Registration
Vedia Solutions, Division of Laxmi Dental Limited Registration: 3016455588 View Registration
PACIFIC DENTAL SERVICES Registration: 3016506311 View Registration
ALPHA-BIO TEC Registration: 3016672944 View Registration
GUNTER MEDICAL GMBH Registration: 3016733895 View Registration
NEWTON IMPLANT SYSTEMS Registration: 3016784205 View Registration
Microdental Laboratories Registration: 3016855296 View Registration
CHANGZHOU SIFARY MEDICAL TECHNOLOGY CO., LTD. Registration: 3016875543 View Registration
IMPLANT PROTESIS DENTAL 2004, S.L. Registration: 3016954909 View Registration
COMFORT SURGICAL INSTRUMENTS Registration: 3016965929 View Registration
SHOWCASE DENTAL LAB LLC Registration: 3016986305 View Registration
GLOBAL DENTAL TRANSFER LTD Registration: 3017013344 View Registration
MEDEALIS GMBH Registration: 3017064961 View Registration
ZENTEK MEDICAL LLC Registration: 3017125693 View Registration
ODS CO., LTD. Registration: 3017210293 View Registration
STRATASYS LTD - Headquarter Registration: 3017374693 View Registration
NEOSS AB Registration: 3017399129 View Registration
HIOSSEN, INC. Registration: 3017450159 View Registration
RIELLENS INDUSTRIA E COMERCIO LTDA Registration: 3017508379 View Registration
Oneday Biotech Co., Ltd. Registration: 3017548645 View Registration
IMPLANT CONCIERGE Registration: 3017565026 View Registration
ZHONGSHAN SAXIN ELECTRIC HEATING TECHNOLOGY CO., LTD. Registration: 3017607477 View Registration
GEOMEDI CO., LTD. Registration: 3017691835 View Registration
REOSS GMBH Registration: 3017734069 View Registration
Dentauspex Corporation Registration: 3017833095 View Registration
VERSAH, LLC Registration: 3017835246 View Registration
LA PRECISION INDUSTRY Registration: 3017840051 View Registration
EXCELLENT PRECISION TECHNOLOGY (DONGGUAN) CO., LTD Registration: 3017896270 View Registration
FSEVEN DENTAL TECHNOLOGY ZHUHAI CO.,LTD Registration: 3017903664 View Registration
Precision One Medical Registration: 3017980266 View Registration
MK MEDITECH Registration: 3018070878 View Registration
MEDIHUB CO., LTD. Registration: 3018077478 View Registration
IZENIMPLANT CO., LTD. Registration: 3018097239 View Registration
IMPLANT SOLUTIONS PTY LTD (TRADING AS OSTEON MEDICAL) Registration: 3018501314 View Registration
D.S.P. INDUSTRIAL EIRELI EPP Registration: 3018662547 View Registration
ALLIEDSTAR MEDICAL EQUIPMENT CO., LTD. Registration: 3018994222 View Registration
PREFERRED ORAL DESIGN LIMITADA Registration: 3019252621 View Registration
Aceso Dental Laboratory Company Limited Registration: 3019793783 View Registration
SHENZHEN HLD DENTAL&TECHNOLOGY CO.,LTD Registration: 3019909974 View Registration
3BFAB TEKNOLOJI ANONIM SIRKETI Registration: 3020702076 View Registration
YAMAHACHI DENTAL MFG. CO. Registration: 3020841418 View Registration
ZIYANG FREQTY MEDICAL EQUIPMENT CO., LTD. Registration: 3020984550 View Registration
WUXI LYUSMILE IMP AND EXP CO.,LTD Registration: 3021023132 View Registration
NINGBO SEZEN TECHNOLOGY CO., LTD. Registration: 3021024355 View Registration
ABRACADABRA IMPLANTS LTD. Registration: 3021076825 View Registration
GUANGZHOU HEYGEARS IMC.INC Registration: 3021381014 View Registration
DTS DIGITAL DENTAL LAB Registration: 3021964955 View Registration
SHENZHEN YONGCHANGHE TECHNOLOGY CO., LTD. Registration: 3022519816 View Registration
COREMEDTECH APS Registration: 3022806627 View Registration
BEIJING YINGGUAN DENTAL SCIENCE&TECHNOLOGY CO.,LTD. Registration: 3023248501 View Registration
PHEN'X TECHNOLOGIES Registration: 3023265483 View Registration
HENAN BAISTRA MEDICAL DEVICES LIMITED Registration: 3023443842 View Registration
Hipp Medical AG Registration: 3023852420 View Registration
Straumann Manufacturing, Inc. Registration: 3024185724 View Registration
ASIGA Registration: 3024227208 View Registration
SPRINTRAY INC. Registration: 3024749697 View Registration
SNUCONE CO., LTD. Registration: 3024858450 View Registration
T. STRONG INC. Registration: 3024859204 View Registration
SENTRONIC INTERNATIONAL CORP. Registration: 3025325119 View Registration
OSSVIS CO., LTD. Registration: 3025338240 View Registration
United Laboratories Corporation Registration: 3025634069 View Registration
WELL MEDICAL Registration: 3025873468 View Registration
ZHUHAI MEIERJING MEDICAL INSTRUMENT CO., LTD. Registration: 3026284340 View Registration
HANGZHOU SHINING3D DENTAL TECHNOLOGY CO., LTD Registration: 3026312357 View Registration
HADER Solutions & Distribution Ltd Registration: 3026401444 View Registration
Medentika GmbH Registration: 3026444199 View Registration
Riton 3D Technology Co., Ltd Registration: 3027303702 View Registration
SUZHOU LAIXIN 3D TECHNOLOGY CO.,LTD Registration: 3027508795 View Registration
Loyol New Material Suhzou Co.,Ltd. Registration: 3027520370 View Registration
MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. Registration: 3027526455 View Registration
OPEN IMPLANTS Registration: 3027595870 View Registration
INFINITUM ETA LTD. Registration: 3027665899 View Registration
ECLECTIC INC. Registration: 3029820793 View Registration
BES DEPOT, LLC Registration: 3029895607 View Registration
KAUL MEDIZINTECHNIK GMBH Registration: 3029933740 View Registration
PNUAdd Co., Ltd. Registration: 3029973772 View Registration
DMI TECHNOLOGY LLC Registration: 3030039110 View Registration
MegaGen Implant Co., Ltd. (Research Laboratories) Registration: 3030089802 View Registration
ONVET MEDICAL CANADA INC Registration: 3030126955 View Registration
APPLY LABWORK INC. Registration: 3030181318 View Registration
ATOMICA TECHNOLOGY, INC Registration: 3030228551 View Registration
Smyles Above Innovations, Inc Registration: 3030228577 View Registration
ORANGECAD MED GMBH Registration: 3030488649 View Registration
Amann Girrbach AG Registration: 3030515618 View Registration
DANTECH DIGITAL DENTAL SOLUTIONS PRIVATE LIMITED Registration: 3030516430 View Registration
ENDONEST MEDICAL SYSTEMS LLP Registration: 3030516433 View Registration
PENGBO (SHENZHEN) MEDICAL TECHNOLOGY CO., LTD. Registration: 3030671632 View Registration
OSSEO PURE INC Registration: 3030863060 View Registration
GUIDED SMILE Registration: 3030896107 View Registration
BLUE ELEPHANT INC Registration: 3031025053 View Registration
SHANDONG HENGFENG KERUI MEDICAL EQUIPMENT CO., LTD Registration: 3031191035 View Registration
SHENZHEN DAZHOU MEDICAL TECHNOLOGY CO., LTD. Registration: 3031235905 View Registration
IMPLANT ATTACHMENTS LLC Registration: 3031303433 View Registration
IZENIMPLANT CO., LTD. Registration: 3031493119 View Registration
MOZO-GRAU SA Registration: 3031553803 View Registration
SHANGHAI LIONS INDUSTRIAL CO.,LTD. Registration: 3031582434 View Registration
Solventum US LLC Registration: 3031841433 View Registration
OSSTEM IMPLANT CO., LTD. Registration: 3031886796 View Registration
APOLLO IMPLANT COMPONENTS Sp. z o.o. Registration: 3032078590 View Registration
Solventum US LLC Registration: 3032163716 View Registration
AXIODENT INC. Registration: 3032312561 View Registration
ZEROS CO., LTD. Registration: 3032439351 View Registration
ZIMA INTERNATIONAL, INC. Registration: 3032802037 View Registration
FULL ARCH TECHNOLOGIES LTD Registration: 3033436335 View Registration
RDJ TOV IMPLANT LTD Registration: 3033524692 View Registration
PARAGON IMPLANT COMPANY, LLC Registration: 3033708818 View Registration
Straumann Manufacturing, Inc. Registration: 3033781108 View Registration
The American Angle, LLC Registration: 3034725654 View Registration
ALLONUS TECH CO., LTD. Registration: 3035532393 View Registration
BIOABUTMENT INC. Registration: 3035532394 View Registration
DIGITAL ARCHES INC. Registration: 3035983708 View Registration
Dentis Co.,Ltd Registration: 3036190511 View Registration
GUANGXI EHALL MEDICAL TECHNOLOGY CO.,LTD Registration: 3036269993 View Registration
QUICKDENT DEVICES PRIVATE LIMITED Registration: 3036779616 View Registration
KLS MARTIN SE & CO. KG Registration: 3036795921 View Registration
LX PRECISION PORTUGAL, UNIPESSOAL, LDA Registration: 3038136479 View Registration
KTJ DENTAL LAB INC Registration: 3038181756 View Registration
Aidite (Shenzhen) Medical Technology Co., Ltd Registration: 3038195217 View Registration
SKY HKMC INTERNATIONAL LIMITED Registration: 3038290056 View Registration
INFINETAMED AG Registration: 3038549074 View Registration
TF NEW MATERIAL SCI AND TEC CO.,LTD Registration: 3038632739 View Registration
SMD DENTAL LABORATORY Registration: 3038715999 View Registration
XIAMEN XIANG JI PRECISION MACHINERY TECHNOLOGY CO., LTD Registration: 3039698130 View Registration
HUB BIOTECH CO., LTD. Registration: 3042200066 View Registration
AMG DENTAL LTD Registration: 3042227762 View Registration
SOLVENTUM US LLC Registration: 3042272797 View Registration
COVISION CO., LTD. Registration: 3042852773 View Registration
OSSEO MAX INC Registration: 3042927692 View Registration
SHINSAEGI MEDI-TECH CO., LTD. Registration: 3042969838 View Registration
DIMPLO Ltd. Registration: 3042971970 View Registration
GUANGDONG ZHILIANXING PRECISION TECHNOLOGY CO.,LTD. Registration: 3043105508 View Registration
HANGZHOU WISE MEDICAL DEVICE CO.,LTD Registration: 3043149181 View Registration
ZAPALIGN LLC Registration: 3043226252 View Registration
ONE DAY DENTAL PARTNER Registration: 3043303267 View Registration
SURCAM MEDICAL DEVICES AND DEVELOPMENTS LTD Registration: 3043585140 View Registration
RP CONEXOES RESTAURADORAS LTDA Registration: 3043618669 View Registration
DEBO MEDICAL TECHNOLOGY (SHIJIAZHUANG) CO., LTD. Registration: 3043648115 View Registration
PALAXA PRECISION LLC Registration: 3043841530 View Registration
MODERN DENTAL LABORATORY USA, LLC Registration: 3043842086 View Registration
Shanghai Jolly Industrial Co., Ltd. Registration: 3044150131 View Registration
XIAMEN ANTINSKY INDUSTRY CO., LTD Registration: 3044921218 View Registration
EDENTAL LAB CO., LTD Registration: 3045005836 View Registration
MEDICON, E.G. Registration: 8010099 View Registration
A. SCHWEICKHARDT GMBH & CO. KG Registration: 8010159 View Registration
STRYKER LEIBINGER GMBH & CO. KG Registration: 8010177 View Registration
GEBR. BRASSELER GMBH & CO. KG Registration: 8010468 View Registration
HAGER & MEISINGER GMBH Registration: 8010516 View Registration
Faulhaber Pinzetten KG Registration: 8010591 View Registration
Kohler Medizintechnik GmbH Registration: 8010732 View Registration
VOCO GMBH Registration: 8010908 View Registration
ANTHOGYR Registration: 8020776 View Registration
FFDM TIVOLY Registration: 8023007 View Registration
VERTEX-DENTAL B.V. Registration: 8030452 View Registration
DENTATUS AB Registration: 8030870 View Registration
MAILLEFER INSTRUMENTS HOLDING SARL Registration: 8031010 View Registration
CENDRES+METAUX SA Registration: 8031058 View Registration
Falcon Surgical Co. (Pvt.) Ltd. Registration: 8040278 View Registration
ACCOMPANY SURGICAL Registration: 8041151 View Registration
STORZ AM MARK GMBH Registration: 8043554 View Registration
STERIS Schweiz AG Registration: 8043792 View Registration
FORESTADENT BERNHARD FORSTER GMBH Registration: 8044058 View Registration
WESLEY COE (CAMBRIDGE) LTD Registration: 8044131 View Registration
KLS Martin SE & Co. KG Registration: 9610905 View Registration
HEBUMEDICAL GMBH Registration: 9611112 View Registration
NAKANISHI INC. Registration: 9611253 View Registration
HELMUT ZEPF MEDIZINTECHNIK GMBH Registration: 9611367 View Registration
DENTECH CORP. Registration: 9611450 View Registration
Dentaurum GmbH & Co. KG Registration: 9611458 View Registration
NOBEL BIOCARE AB Registration: 9611992 View Registration
NOBEL BIOCARE AB, PRODUKTION Registration: 9611993 View Registration
IVOCLAR VIVADENT AG Registration: 9612352 View Registration
Dentsply IH AB Registration: 9612468 View Registration
HI TEC IMPLANTS, LTD. Registration: 9613283 View Registration
INSTITUT STRAUMANN AG Registration: 9613348 View Registration
ALTATEC GMBH Registration: 9613866 View Registration
TRACK OF SURGICAL Registration: 9614068 View Registration
Straumann Villeret SA Registration: 9614404 View Registration
SIRONA DENTAL SYSTEMS GMBH Registration: 9614977 View Registration
OSUNG MND CO., LTD. Registration: 9616119 View Registration
SOADCO, S.L. Registration: 9617542 View Registration
STECO-SYSTEM-TECHNIK GMBH & CO. KG Registration: 9617660 View Registration
DEN TAG S.R.L. Registration: 9680026 View Registration
MEDESY srl Registration: 9680244 View Registration
JOSEF GANTER FEINMECHANIK GMBH Registration: 9680605 View Registration
SDS de Mexico S. de R.L. de C.V. Registration: 9680845 View Registration
RHEIN 83 SRL Registration: 9680939 View Registration
DETAX GMBH Registration: 9680954 View Registration
DEGUDENT GMBH Registration: 9681199 View Registration
W&H DENTALWERK BUERMOOS GMBH Registration: 9681479 View Registration
Sirona Dental Systems GmbH Registration: 9681851 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0016-2022

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer