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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cement, dental
Regulation Description Dental cement.
Product CodeEMA
Regulation Number 872.3275
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 5
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 16
AMERICAN ORTHODONTICS
  SUBSTANTIALLY EQUIVALENT 1
CLOSURE MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONFI-DENTAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 8
ESPE DENTAL
  SUBSTANTIALLY EQUIVALENT 2
GLUSTITCH, INC.
  SUBSTANTIALLY EQUIVALENT 2
HAGER WORLDWIDE, INC.
  SUBSTANTIALLY EQUIVALENT 1
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 5
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 3
KULZER
  SUBSTANTIALLY EQUIVALENT 1
OROSCIENCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 8
STAR DENTAL MFG. CO.
  SUBSTANTIALLY EQUIVALENT 1
SYBRON
  SUBSTANTIALLY EQUIVALENT 2
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 8
WELCH ALLYN, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No code available 53
Patient-device incompatibility 16
No Known Device Problem 9
Loss of or failure to bond 4
Sensitivity 4
Component falling 3
Detachment of device component 2
Incompatibility problem 2
Material integrity issue 1
Failure to Adhere or Bond 1
Material discolored 1
Dislodged 1
Loose 1
Total Device Problems 98

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 1 5 0 0 0 0
Class III 0 0 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bisco Inc II Aug-25-2008
2 Henry Schein, Inc. II Jan-11-2012
3 Kerr Corp III Oct-23-2009
4 Kerr Corporation II Mar-14-2012
5 Kerr Corporation II Feb-24-2012
6 Kerr Corporation II Jan-11-2012
7 Kerr/pentron Dba Kerr Corporation And Pentron Clinical II Jan-11-2012
8 Kerr/pentron Dba Kerr Corporation And Pentron Clinical II Nov-14-2011

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