• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 165
No Known Device Problem 20
Loss of or failure to bond 18
Failure to Adhere or Bond 16
Patient-device incompatibility 15
Device operates differently than expected 7
Improper or incorrect procedure or method 7
Contamination during use 5
Fracture 3
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 271

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 1 1 0 1 0 3 1 0 1 0
Class III 0 0 0 1 1 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

-
-