FDA Device Recall Z-0035-2008: Heraeus Kulzer Inc., Dental Products Division

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0035-2008.

Recall Res Number

Z-0035-2008

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

1,236

Product Description Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.

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
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Kerr Corporation Registration: 2024312 View Registration
YOUNG INNOVATIONS INC. Registration: 2024980 View Registration
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PAC-DENT INC. Registration: 2086043 View Registration
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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
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DENTSPLY LLC Registration: 2515379 View Registration
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GC CORPORATION-FUJI OYAMA FACTORY Registration: 3002807050 View Registration
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VERICOM CO., LTD. Registration: 3003449480 View Registration
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DENTSCARE LTDA Registration: 3007210751 View Registration
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Keystone Industries - Gibbstown Registration: 3010002722 View Registration
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Medical Device Recall: Z-0035-2008

Recall Parameters & Description

Related Establishments / Registrations

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