Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011276344

FEI Number

3011276344

Entity Name

SWEDEN & MARTINA INC

City/State/Country

Naperville, IL, US

Establishment Address

916 SPINDLETREE AVENUE, Naperville, IL 60565, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Sweden & Martina INC (Owner Number: 10048147)

Owner / Operator Contact Address

916 SPINDLETREE AVENUE, Naperville, IL 60565, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K093122

PMA Number

N/A

All Registered Proprietary Names

BONE GRAFTING MATERIAL, HUMAN BONE GRAFTING MATERIAL IN DELIVERY APPLICATOR PREMIUM ONE Sutures ECLIPSE OSSIX PLUS CHISEL (OSTEOTOME) GUTTA-PERCHA POINTS FULL BODY POST BRIDGE 12 ELEMENTS ARCHIPLAN SOFTWARE DESIGN ARCHIPLAN ARCHIPLAN SOFTWARE PRO REAL GUIDE ARCHIPLAN SOFTWARE CAD OPEN TEX Bone Grafting Material COLLAGEN DENTAL MEMBRANE REMOVER, CROWN MILLABLE TITANIUM ABUTMENT MILLABLE TITANIUM SLEEVE NEOMEM FLEX PLUS Volumax CONTRAANGLE FOR SURGERY 20:1 CONTRAANGLE FOR SURGERY 1:1 REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 8.5 MM SUPPLEMENTARY DRILLS SET LONG DRILL DIAM. 4,25 MM REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 13 MM LONG DRILL DIAM. 3,60 MM REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 11.5 MM TRANSFER P.A.D. FOR CAD-CAM STOP H.8 MM FOR DRILL TRANSFER 3.30 PR/SH SHORT DRILL DIAM. 2,00 MM SHORT STOP H. 8,5, D. 5,50 MM ROUND TIP OSTEOTOME FOR SHELTA KIT D.B.E. SYSTEM REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 13 MM PREMIUM BONE PROFILER LONG DRILL DIAM. 3,30 MM PREMIUM SURGICAL KIT ECHOPLAN COUNTERSINK DRILL PARALLELISM PIN WITH DEPTH LONG STOP H. 15, D. 4,15 MM STOP H.6 MM FOR DRILL INSTRUMENTS TRAY FOR REPLY FOR SHELTA IMPLANT D. 50 MM, L. 11.5 MM STOP H.7 MM FOR DRILL UNIVERSAL INITIAL MUCOTOME SURGICAL KIT FOR PRAMA SURGICAL KIT FOR PRE/KOH IMPLANT SYSTEM SURGICAL KIT ONEBOX FOR PREMIUM IMPLANT SYSTEM CHAMFERED DRILL D. 30 MM ABUTMENT ECHO PREMIUM-KOHNO COUNTERSINK DRILL D.4.10 MM STOP FOR CONICAL DRILL REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 10 MM SHORT STOP H. 10, D. 4,15 MM PRE-MADE REP. ABUT STRAIGHT X-RAY TEMPLATES LONG DRILL DIAM. 2,50 MM PRECISION DRILL REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 15 MM REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 15 MM REPLY FOR SHELTA IMPLANT D. 50 MM, L. 8.5 MM SURGICAL KIT "ONEBOX" SHORT STOP H. 8,5, D. 4,15 MM FINAL CONICAL DRILL GLOBAL PERI-SET , KIT FOR SURGICAL TRANSFER ECHO FOR GLOBAL M.I.S.E. EVO KIT LONG SCREW DRIVER FOR LOCATOR SURGICAL KIT FOR GLOBAL IMPLANT SYSTEM FINAL CONICAL DRILL SHELTA O-RING KIT FOR INSTRUMENTS ABUTMENT ECHO KOHNO ABUTMENT ECHO GLOBAL FLAT TIP OSTEOTOME FOR SHELTA STOP H.4 MM FOR DRILL COUNTERSINK FOR PREMIUM SP MILLABLE TITANIUM ABUTMENT INTERMEDIATE DRILL HAND DRIVER FOR ABUTMENT LONG SURGIC. HAND SCREWDRIVER CYLINDRICAL FINAL DRILL STOP H.2 MM FOR DRILL NON RETENT. LONG HAND DRIVER REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 13 MM RIGHT ANGLE RETENTIVE DRIVER PULL-UP TRANSFER REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 10 MM TITANIUM SLEEVE UNIVERSAL BONE PROFILER BONE TAP PREMIUM D. 3,80 MM REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 15 MM INTRAORAL SCANBODY TEMPORARY ABUTMENT REMOVAL SCREW KIT FOR GLOBAL LONG DRILL DIAM. 3,40 MM REMOVAL SCREW KIT FOR PRE/KOH CSR STOP FOR CYLINDRICAL DRILL TAPERED FINAL DRILL REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 11.5 MM SHORTY DRILLING KIT STOP H.9 MM FOR DRILL LONG DRILL DIAM. 2,00 MM SURGICAL KIT FOR SHELTA IMPLANT SYSTEM STOP H.3 MM FOR DRILL CLOSED TRAY TRANSFER SURGICAL KIT ECHOPLAN PRO REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 15 MM PEEK CAP FOR PREMADE POST GLOBAL BONE EXPANDER KIT SHORT SCREW DRIVER FOR LOCATOR DEPTH GAUGE HOLE IMPLANTS PARALLEL PIN ABUTMENT ECHO OUTLINK2 POST SCREW FOR PRAMA IMPLANT ROUND TIP OSTEOTOME FOR GLOBAL SURGICAL SLEEVE WITH HEX.DIAM. NON RETENTIVE DIGITAL DRIVER STOP FOR CYLINDRICAL DRILL INSTRUMENT TRAY ECHOPLAN BONE TAP PREMIUM SP D.3,80 MM REMOVAL SCREW KIT FOR OUTLINK2 MOUNTER OUTLINK2 D. 3,30 MM TI POST ANATOMICAL FINAL CONICAL DRILL SYRA SHORT STOP FOR CONICAL SYRA SHORT PICK-UP TRANSFER FOR PRAMA CASTABLE POST,NON REP., GOLD BONE TAP PREMIUM D. 4,25 MM TEFLON CAP BALL ATTACHMENTS PRE-MADE REP. ABUT ANATOMICAL REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 11.5 MM SHORT DRILL DIAM. 2,90 MM DOUBLE MOUNTER STOP KEY FOR REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 13 MM RETENT.SHORT R.A. EASY INSERT ABUTMENT SCREW M1.8 SHORT DRILL DIAM. 3,80 MM REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 10 MM RETENT.EASY INSERT HAND DRIVER TRANSFER 50 PR/SH REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 8.5 MM HAND BONE TAP FOR GLOBAL LONG DIGITAL RETENTIVE DRIVER REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 8.5 MM X-RAY TEMPLATES FOR PRAMA AND SCANBODY iNTRAORAL ANALOGUE FOR ABUTMENT CYLINDRICAL PILOT DRILL PILOT DRILL HAND BONE TAP FOR KOHNO BONE TAP PREMIUM D. 5,00 MM LONG DRILL DIAM. 3,20 MM BONE PROFILER SLEEVE SHORT PROSTHETIC HAND SURGICAL SLEEVE DIAM. 5,50 MM REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 13 MM SHORT DRILL DIAM. 4,25 MM SURGICAL KIT ECHOPLAN SUPPLEMENTARY KIT PREMIUM SHORT SURGIC. HAND SCREWDRIVER SILICONE SUPPORT FOR SURGICAL STOP H.10 MM FOR DRILL SHORT DRILL DIAM. 3,30 MM SHORT DRILL DIAM. 3,20 MM OUTLINK2 SUPPLEMENTARY INSTR. BONE EXPANDER FOR D.B.E REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 8.5 MM TRY-IN KIT FOR PREMIUM RETENT.LONG R.A. EASY INSERT CONCAVE TIP OSTEOTOME D.2.40 HEXAGONAL SCREWDRIVER FOR HAND DRIVER FOR R.A. INSTRUM. HOLDER FOR PREMIUM SP SHORT STOP H. 10, D. 5,50 MM BONE TAP PRE/OUT D. 3,30 MM HAND SCREWDRIVER FOR BALL EXTENSION FOR SURGICAL DRILLS EXTRA LONG PROSTHETIC HAND REPLY FOR GLOBAL IMPLANT HAND DRIVER FOR TITANIUM CAP TRANSFER ECHO FOR PREMIUM MOUNTER WITH SCREW FOR PRE/KOH SURGICAL HAND SCREWDRIVER FOR SHORT DIGITAL RETENT. DRIVER LONG STOP H. 13, D. 5,50 MM TORQUE CONTROLLED RATCHET KIT SHORT STOP H. 11,5, D. 4,15 MM STOP H.5 MM FOR DRILL SHORT DRILL DIAM. 2,50 MM SHORT DRILL DIAM. 4,00 MM PILOT DRILL GLOBAL NON RETENT. SHORT HAND DRIVER CARRIER FOR ANGLED ABUTMENT PRE/KOH BONE PROFILER "SURGICAL KIT ""ONEBOX2""" ABUTMENT ECHO PREMIUM REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 8.5 MM LONG DRILL DIAM. 2,80 MM REPLY FOR SHELTA IMPLANT PINS DRILL HAND BONE TAP FOR PRE/KOH SURGICAL KIT FOR PREMIUM IMPLANT SYSTEM INITIAL DRILL BUILT-IN STOP XS SURGICAL HAND SCREWDRIVER SHORT DRILL DIAM. 2,80 MM LONG DRILL DIAM. 3,00 MM EXTENSION FOR HAND SCREWDRIVER REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 8.5 MM LONG DRIVER FOR GLOBAL IMPL. MOUNTER OUTLINK2 D. 4,10 MM RIGHT ANGLE SCREWDRIVER FOR REPLIES FOR SHELTA IMPLANTS SUPPLEMENTARY KIT OUTLINK2 REPLY FOR SHELTA IMPLANT D. 50 MM, L. 10 MM RIGHT ANGLE CONNECTOR REPLY FOR GLOBAL IMPLANT D. 4.30 MM, L. 10 MM CASTABLE POST,NON REP., CR-CO HAND BONE TAP FOR PREMIUM "SURGICAL KIT ""ONEBOX""" SHORT DRILL DIAM. 3,60 MM SHORT HAND BONE TAP BONE TAP FOR OUTLINK2 TRANSFER ECHO FOR PRE-KOH TG FINAL CYLINDRICAL DRILL ABUTMENT SCREW M 2 LONG STOP H. 15, D. 5,50 MM MILLABLE TITANIUM SLEEVE EXTRA SHORT SURGICAL HAND SHORT STOP H. 7, D. 5,50 MM ROUNDED DRILL D. 3.40 MM TRANSFER ECHO FOR OUTLINK2 BRUSH SURGICAL SLEEVE DIAM. 4,15 MM DOUBLE TIP PLUGGER REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 11.5 MM REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 15 MM GLOBAL BONE PROFILER REPLY FOR SHELTA IMPLANT D. 4.25 MM, L. 10 MM ROUND TIP OSTEOTOME D.20 STOP H.1 MM FOR DRILL REPLY FOR SHELTA IMPLANT D. 3.80 MM, L. 10 MM SHORT DRILL DIAM. 3,40 MM MOUNTER PRAMA, FOR SLEEVE CONCAVE TIP OSTEOTOME D.1.60 REPLY FOR SHELTA IMPLANT D. 50 MM, L. 15 MM SURGICAL KIT ONEBOX2 FOR OUTLINK2 IMPLANT SYSTEM COUNTERSINK FOR OUTLINK2 REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 11.5 MM INITIAL DRILL D. 20 MM SILICONE SUPPORT FOR SCREWKIT REPLY FOR GLOBAL IMPLANT D. 3.80 MM, L. 11.5 MM RIGHT ANGLE DRIVER FOR GLOBAL- TEFLON CAP CONTAINER FOR BALL PREMIUM SUPPLEMENTARY INSTR. SURGICAL KIT "ONEBOX2" OUTLINK2 SURGICAL KIT ECHOPLAN RIGHT ANGLE BONE TAP SUPPLEMENTARY INSTRUM. SET LONG DRILL DIAM. 4,00 MM INTERMEDIATE DRILL GLOBAL MOUNTER STOP KEY FOR STOP H.11 MM FOR DRILL SPARE CAST. SLEEVE FOR GOLD RIGHT ANGLE SCREWDRIVER BREAK UP DRILL D. 30 MM INTERMEDIATE DRILL D. 2.50 MM MOUNTER TRAY ORGANIZER SURGICAL KIT FOR OUTLINK2 IMPLANT SYSTEM CASTABLE CAP FOR PREMADE ABUT TORQUE WRENCH WITH LEVER SHORT STOP H. 11,5, D. 5,50 MM TRANSFER 4.25 PR/SH TRY-IN KIT FOR PREMIUM/KOHNO REPLY FOR SHELTA IMPLANT D. 50 MM, L. 13 MM ANCHOR PIN COUNTER ANGLE FOR SURGERY 20:1 ROUNDED DRILL D. 40 MM CONICAL DRILL STOP UNLOCKING HOLDER STOP H.13 MM FOR DRILL MOUNTER OUTLINK2 D. 5,00 MM LONG DRILL DIAM. 3,80 MM TAPERED FINAL DRILL UNDERP. STOP H.12 MM FOR DRILL SURGICAL KIT ROUND TIP OSTEOTOME D.90 SCREW ZIRCONIUM ABUTMENT REPLY FOR GLOBAL IMPLANT D. 5.50 MM, L. 15 MM CONCAVE TIP OSTEOTOME D.20 MOUNTER HAND DRIVER TITANIUM SUPPORT REPLY FOR GLOBAL IMPLANT D. 4.80 MM, L. 13 MM TEMP. CAP FOR PRE-MADE ABUT TRANSFER 3.80 PR/SH STOP UNLOCKING HANDLE LONG STOP H. 13, D. 4,15 MM SURGICAL SLEEVE FOR ANCHOR PIN SCREW KIT HAND BONE TAP FOR SHELTA HEALING CAP FOR PRE-MADE ABUT SHORT STOP H. 7, D. 4,15 MM LONG PROSTHETIC HAND LONG DRILL DIAM. 2,90 MM TAPERED BONE TAP STOP FOR SHORT DRILL HANDLE FOR D.B.E.SYSTEM BOX FOR PRE-MADE ABUTMENT TRANSFER P.A.D. MILLABLE CRCO ABUTMENT ROUNDED DRILL D. 30 MM EXTRALONG PROSTHETIC HAND PLUGGER AND DEPTH GAUGE HOLDER FOR PREMIUM MOUNTER STOP KEY SHORT DRILL DIAM. 3,00 MM SURG. KIT FOR PREMIUM-SHELTA HAND KNOB FOR DRIVERS, BONE PROSTHETIC ACCESSORIES KIT CASTABLE POST, REP., CR-CO TI POST STRAIGHT ANALOGUE FOR PRAMA IMPLANT CRCO POST ANATOMICAL CRCO POST STRAIGHT NECK POSITION PIN CLUTCH DRILL ABUTMENT TIT. D.12 GUIDED SURGERY PIVOT M-TWO INSTRUMENT EASY MOUNTER SPIRAL DRILL INSERTION INSTRUMENT DIGITAL ANALOGUE DEPTH GAUGE STOP H.5,5 MM FOR DRILL SCREW MOUNTER SCREW MOUNTER PIN STOP H.4,5 MM FOR DRILL STOP H.2,5 MM FOR DRILL MUCOTOME PEEK OSTEOTOME TIP CURVED HANDLE STOP H.1,5 MM FOR DRILL EXTRACTOR SCREW DRILL HANDLE MASTER SLEEVE FINAL CONICAL DRILL STOP H.3,5 MM FOR DRILL CYLINDRICAL DRILL BONE GRAFTING MATERIAL Sutures THE GRAFT MOTOR, SURGICAL INSTRUMENT, ACPOWERED Ossix Plus Sutures OMNIA NEOMEM ECM COLLAGEN DENTAL WOUND DRESSING IMPLANT ANGLE HANDPIECE PRE-MADE REP. POST STRAIGHT PLAIN ABUTMENT H2 MM PRE-MADE REP. POST ANATOMICAL MILLABLE REP. POST FOR 30GR ANGLED PAD ABUT., H5 MM CASTABLE REP. POST WITH GOLD 15GR ANGLE PRE-MADE POST, REP. TRANSGINGIVAL HEALING CAP H7MM STRAIGHT PAD ABUTMENT, H4 MM PRE-ANGLED REP. MILLABLE POST TRANSGINGIVAL HEALING CAP H5MM 25GR ANGLE PRE-MADE POST, REP. STRAIGHT PAD ABUTMENT, H1.5 MM SIMPLE TEMP. POST PEEK+TIT REP 30GR ANGLED PAD ABUT., H3 MM SIMPLE TEMP. POST TIT. REP. CASTABLE REP. POST WITH CRCO MILLABLE POST, REP. 17GR ANGLED PAD ABUT., H5 MM CAST. NON REP. POST WITH GOLD 17GR ANGLED PAD ABUT., H3 MM PLAIN ABUTMENT H3 MM TRANSGINGIVAL HEALING CAP H3MM STRAIGHT PAD ABUTMENT, H3 MM SIMPLE TEMP. POST TIT. NON REP PLAIN ABUTMENT H4 MM CAST. NON REP. POST WITH CRCO TRANSGINGIVAL HEALING CAP H2MM M.I.S.E. EVO KIT SURGICAL KIT PREMIUM SUPPLEMENTARY INSTR. SURGICAL KIT ECHOPLAN PRO SURG. KIT FOR PREMIUM-SHELTA SURGICAL KIT "ONEBOX" INSTRUMENT TRAY ECHOPLAN SURGICAL KIT ECHOPLAN OUTLINK2 SUPPLEMENTARY INSTR. SURGICAL KIT "ONEBOX2" KIT D.B.E. SYSTEM GLOBAL BONE EXPANDER KIT PROSTHETIC ACCESSORIES KIT INSTRUMENTS TRAY FOR REMOVAL SCREW KIT BRIDGE 12 ELEMENTS FULL BODY POST PREPARATION DRILLS KIT FOR TEMPORARY BRIDGES FOR B.O.P.T. PREPARATION DRILLS KIT FOR B.O.P.T. DIAMOND BUR SHORTY DRILLING KIT SCREW KIT ECLIPSE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NUN	Bone Grafting Material, Human Source	Dental	Class 2	872.3930	2023-06-08
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2025-05-20
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-02-26
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2017-12-19
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2017-12-19
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2017-12-19
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2017-12-19
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2017-12-19
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2023-06-08
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2018-01-19
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	2022-02-21
EKM	Gutta-Percha	Dental	Class 1	872.3850	2025-06-27
NSM	Restoration, Resin	Unknown	Class N	N/A	2024-03-25
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2023-07-10
NPK	Barrier, Synthetic, Intraoral	Dental	Class 2	872.3930	2023-06-08
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2017-12-21
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2024-03-28
EIS	Remover, Crown	Dental	Class 1	872.4565	2022-02-21
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-08-24
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2023-06-08
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2017-12-20
KMW	Handpiece, Rotary Bone Cutting	Dental	Class 2	872.4120	2021-07-26
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2018-12-03
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2024-03-28
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2017-12-19
NPM	Bone Grafting Material, Animal Source	Dental	Class 2	872.3930	2023-06-08
GEY	Motor, Surgical Instrument, Ac-Powered	General, Plastic Surgery	Class 1	878.4820	2022-02-21
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2016-07-08
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2017-12-19
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2016-10-27
NPL	Barrier, Animal Source, Intraoral	Dental	Class 2	872.3930	2023-06-08
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2025-05-19
EGS	Handpiece, Contra- And Right-Angle Attachment, Dental	Dental	Class 1	872.4200	2025-08-27
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2018-02-26
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2018-02-26
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2023-05-29
NSN	Restoration, Resin, Crown And Bridge	Unknown	Class N	N/A	2024-03-25
DZA	Drill, Dental, Intraoral	Dental	Class 1	872.4130	2018-12-03
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2021-08-25
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2023-06-08

Official Correspondent

Alessia Pezzato

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sweden & Martina INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

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K120793	Z-Systems AG	Z-LOOK3 EVO SLM	2012-12-21
K130140	Intra-Lock International	INTRA-LOCK OP DENTAL IMPLANT	2013-08-01
K925778	Nobelpharma USA, Inc.	BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES	1993-04-14
K903999	O Co., Inc.	OBUTMENT HB	1992-02-11

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Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011276344. Last updated year: 2026. Please use registration number 3011276344 when referencing this establishment in official correspondence.