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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device material, tooth shade, resin
Regulation Description Tooth shade resin material.
Product CodeEBF
Regulation Number 872.3690
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 7
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 21
CONFI-DENTAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 6
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 2
ESPE DENTAL
  SUBSTANTIALLY EQUIVALENT 6
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 8
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 15
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 13
KULZER
  SUBSTANTIALLY EQUIVALENT 14
STAR DENTAL MFG. CO.
  SUBSTANTIALLY EQUIVALENT 1
SYBRON
  SUBSTANTIALLY EQUIVALENT 2
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 14

Device Problems
No code available 225
No Known Device Problem 22
Patient-device incompatibility 19
Loss of or failure to bond 18
Failure to Adhere or Bond 16
Improper or incorrect procedure or method 7
Device operates differently than expected 7
Contamination during use 5
Fracture 4
Use of Device Issue 3
No Information 3
Device handling issue 2
Torn material 1
Dislodged or dislocated 1
Material integrity issue 1
Unknown (for use when the device problem is not known) 1
Loose 1
Nonstandard device or device component 1
Unintended ejection 1
Total Device Problems 338

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 1 0 1 0 3 1 0 1 0 0
Class III 0 0 0 1 1 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Jul-08-2015
2 3M Espe Dental Products II May-11-2007
3 Kerr Corp II Nov-25-2008
4 Kerr Corporation II Feb-28-2012
5 Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical II Sep-19-2013
6 Kerr/pentron Dba Kerr Corporation And Pentron Clinical III Nov-03-2011
7 Patterson Dental Supply, Inc. II Dec-17-2010
8 Sybron Dental Specialties II Feb-13-2012
9 Sybron Dental Specialties II Feb-11-2012
10 Sybron Dental Specialties III Mar-02-2010

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