FDA Device Recall Z-0036-2008: Heraeus Kulzer Inc., Dental Products Division

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0036-2008.

Recall Res Number

Z-0036-2008

Recalling Firm / Manufacturer

Heraeus Kulzer Inc., Dental Products Division

FEI Number

1821514

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2007-07-09

Date Posted

2007-10-02

Date Terminated

2008-03-12

Product Code

KLE

Event Number

44827

Product Quantity

736

Product Description Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

Reason for Recall The material may solidify in the bottle, and thus be rendered unusable.

Action Details Consignees were notified via phone or undated letter sent via fax beginning on or about 7/9/07 and instructed to contact the firm for return authorization/instructions.

Distribution Pattern Nationwide and Canada.

Code Information / Serial Numbers Lot 010065; exp. 02/2009.

Related Establishments / Registrations

FIVE STAR ORTHODONTIC LABORATORY & SUPPLY, INC. Registration: 1000118628 View Registration
B.J.M. LABORATORIES LTD Registration: 1000272892 View Registration
VITA ZAHNFABRIK H. RAUTER GMBH & CO. KG. Registration: 1000625496 View Registration
THE ATLANTA DENTAL SUPPLY COMPANY Registration: 1013257 View Registration
BRASSELER U.S.A. DENTAL, LLC Registration: 1032227 View Registration
BIOMAT SCIENCES, INC. Registration: 1125730 View Registration
PULPDENT CORPORATION Registration: 1215305 View Registration
CENTRIX, INC. Registration: 1281412 View Registration
GC AMERICA INC. Registration: 1410097 View Registration
BEUTLICH PHARMACEUTICALS, LLC Registration: 1413399 View Registration
DENTAL TECHNOLOGIES, INC. Registration: 1413475 View Registration
BISCO, INC. Registration: 1420052 View Registration
RELIANCE ORTHODONTIC PRODUCTS, INC. Registration: 1420089 View Registration
PRIME DENTAL MANUFACTURING, INC. Registration: 1424442 View Registration
COSMEDENT, INC. Registration: 1450653 View Registration
RMO Registration: 1718476 View Registration
Ultradent Products Inc. Registration: 1718912 View Registration
CAO GROUP, INC. Registration: 1725006 View Registration
TP ORTHODONTICS, INC. Registration: 1815540 View Registration
KULZER, LLC Registration: 1821514 View Registration
The Belport Company, Inc DBA Gingi-Pak Registration: 2014676 View Registration
DEN-MAT HOLDINGS, LLC Registration: 2018957 View Registration
SCIENTIFIC PHARMACEUTICALS, INC. Registration: 2022039 View Registration
ZEST ANCHORS, LLC Registration: 2023950 View Registration
Kerr Corporation Registration: 2024312 View Registration
YOUNG INNOVATIONS INC. Registration: 2024980 View Registration
DENT ZAR, INC. Registration: 2027375 View Registration
J. MORITA USA, INC. Registration: 2081055 View Registration
PAC-DENT INC. Registration: 2086043 View Registration
AMERICAN ORTHODONTICS Registration: 2126683 View Registration
INTER-MED, INC. Registration: 2133714 View Registration
PATTERSON DENTAL SUPPLY, INC. Registration: 2183301 View Registration
DMG America LLC Registration: 2244812 View Registration
Ivoclar Vivadent Manufacturing, Inc Registration: 2244842 View Registration
PARKELL, INC. Registration: 2411797 View Registration
DENTSPLY LLC Registration: 2424472 View Registration
TEMREX CORP. Registration: 2429849 View Registration
ESSENTIAL DENTAL SYSTEMS, INC. Registration: 2433629 View Registration
CARGUS INT'L, INC. Registration: 2437780 View Registration
PREMIER DENTAL PRODUCTS CO. Registration: 2511556 View Registration
DENTSPLY LLC Registration: 2515379 View Registration
Keystone Industries Registration: 2523320 View Registration
SHOFU DENTAL CORP. Registration: 2916735 View Registration
Patterson Dental Canada Inc. Registration: 3000219976 View Registration
DELTAMED GMBH Registration: 3002789526 View Registration
GC CORPORATION-FUJI OYAMA FACTORY Registration: 3002807050 View Registration
KURARAY NORITAKE DENTAL NIIGATA PLANT Registration: 3002807420 View Registration
SHOFU INC. Registration: 3002808149 View Registration
KASH SALES INC. Registration: 3003120666 View Registration
VERICOM CO., LTD. Registration: 3003449480 View Registration
TOKUYAMA DENTAL CORPORATION Kashima Factory Registration: 3003621174 View Registration
SDI LTD. Registration: 3004140838 View Registration
PREMIUM PLUS DENTAL SUPPLIES INC Registration: 3004425647 View Registration
CAO (CHINA) MEDICAL EQUIPMENT COMPANY, LIMITED Registration: 3004475754 View Registration
Ivoclar Vivadent GmbH Registration: 3004966444 View Registration
IMICRYL DIS MALZEMELERI SANAYI VE TICARET A.S. Registration: 3005176727 View Registration
PREVEST DENPRO LIMITED Registration: 3005628474 View Registration
KULZER GMBH Registration: 3005665377 View Registration
Klema Dentalprodukte GMBH Registration: 3005974404 View Registration
SPIDENT CO., LTD. Registration: 3006113314 View Registration
GENOSS Co., Ltd. Registration: 3006223010 View Registration
PRAIS RELIABLE DENTAL SUPPLIES S.A Registration: 3006316962 View Registration
indigodental GmbH Registration: 3006694515 View Registration
medmix Deutschland GmbH Registration: 3007113445 View Registration
DENTSCARE LTDA Registration: 3007210751 View Registration
MANI MEDICAL GERMANY GmbH Registration: 3007584711 View Registration
US ORTHODONTIC PRODUCTS Registration: 3008005217 View Registration
Liaoning Upcera Co.,Ltd Registration: 3008254125 View Registration
INTERNATIONAL ORTHODONTIC SERVICES, PC Registration: 3008524225 View Registration
SAREMCO DENTAL AG Registration: 3008582054 View Registration
Xplora USA LLC Registration: 3008882689 View Registration
SAMTRADE SUPPLIES INC. Registration: 3008912871 View Registration
DMP Dental Industry S.A. Registration: 3008966075 View Registration
IVOCLAR VIVADENT, INC. Registration: 3009496224 View Registration
ELEVATE ORAL CARE, LLC Registration: 3009603151 View Registration
Keystone Industries - Gibbstown Registration: 3010002722 View Registration
Dharma Research/Medeco International Registration: 3010131268 View Registration
SIGNA MEDICAL, INC. Registration: 3010419931 View Registration
Danville Materials Research Center Registration: 3010664129 View Registration
3D DENTAL DESINGS AND DEVELOPMENT Registration: 3010864832 View Registration
EDELWEISSDR AG Registration: 3011148229 View Registration
PRISMATIK DENTALCRAFT, INC. Registration: 3011649314 View Registration
DYLAN LUCAS INTERNATIONAL INC Registration: 3011689956 View Registration
DENTSPLY IH BV Registration: 3011824442 View Registration
JERSEY DENTAL SUPPLIES Registration: 3012187973 View Registration
MHM GRUPO DIAMANTE, S.A. DE C.V. Registration: 3012354669 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
Kerr Corporation Registration: 3012477813 View Registration
SANICURE BV Registration: 3012494290 View Registration
HI MEDICAL CO., LTD. Registration: 3012502601 View Registration
BINA LIMITED Registration: 3012627824 View Registration
HEALTHDENT'L, LLC Registration: 3013411964 View Registration
Ormco Corporation Registration: 3013508670 View Registration
Itena Clinical Villepinte Registration: 3013557697 View Registration
MEDICLUS CO., LTD Registration: 3013584861 View Registration
M/S LEIXIR RESOURCES PVT. LTD Registration: 3014270094 View Registration
HEXA DENTAL Registration: 3014615644 View Registration
JMU DENTAL, INC Registration: 3014683120 View Registration
NOBIO LTD. Registration: 3015189878 View Registration
Ormco Corporation Registration: 3015272949 View Registration
RIZHAO HUGE BIOMATERIALS COMPANY, LTD. Registration: 3017674095 View Registration
SINO-DENTEX CO.,LTD Registration: 3018283083 View Registration
NAM HA VIET NAM TRADING COMPANY LIMITED Registration: 3018507299 View Registration
ZIRCON PLUS LIMITED Registration: 3026400121 View Registration
F & A LABORATORIO FARMACEUTICO LTDA Registration: 3027584973 View Registration
RIBBOND, INC. Registration: 3027616 View Registration
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Solventum Orthodontics Corporation Registration: 3032027578 View Registration
Solventum US LLC Registration: 3032163716 View Registration
AXIODENT INC. Registration: 3032312561 View Registration
Kerr Corporation Registration: 3032378317 View Registration
Solventum Germany GmbH Registration: 3035693034 View Registration
SINCERA TECHNOLOGY (CHANGCHUN) CO., LTD Registration: 3038295269 View Registration
OKETZ LOGISTICS LLC Registration: 3038718579 View Registration
SHENZHEN UPCERA DIGITAL DENTAL TECHNOLOGY CO., LTD Registration: 3039433962 View Registration
SOLVENTUM US LLC Registration: 3042272797 View Registration
ZAPALIGN LLC Registration: 3043226252 View Registration
DENTSPLY DETREY GmbH Registration: 8010638 View Registration
SCHUETZ DENTAL GMBH Registration: 8010711 View Registration
VOCO GMBH Registration: 8010908 View Registration
Kerr Italia, S.r.l. Registration: 8020994 View Registration
SILMET LTD. Registration: 8030067 View Registration
ADVANCED HEALTHCARE LTD. Registration: 8044038 View Registration
DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH Registration: 8044164 View Registration
KULZER GMBH Registration: 9610902 View Registration
Solventum Germany GmbH Registration: 9611385 View Registration
GC CORP. Registration: 9612300 View Registration
IVOCLAR VIVADENT AG Registration: 9612352 View Registration
COLTENE/WHALEDENT AG Registration: 9613375 View Registration
GC DENTAL PRODUCTS CORP. Registration: 9613953 View Registration
CAVEX HOLLAND B.V. Registration: 9614573 View Registration
DIADENT GROUP INTL., INC. Registration: 9615399 View Registration
DIADENT GROUP INTERNATIONAL Registration: 9616128 View Registration
IDENTA DENTAL MATERIAL GMBH Registration: 9680144 View Registration
SDS de Mexico S. de R.L. de C.V. Registration: 9680845 View Registration
S & C POLYMER GMBH Registration: 9681210 View Registration
META BIOMED CO., LTD. Registration: 9681254 View Registration
KETTENBACH GMBH & CO KG Registration: 9681356 View Registration

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Medical Device Recall: Z-0036-2008

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer