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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device agent, tooth bonding, resin
Regulation Description Resin tooth bonding agent.
Product CodeKLE
Regulation Number 872.3200
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 5
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 7
BLOCK
  SUBSTANTIALLY EQUIVALENT 1
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 3
CONFI-DENTAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 2
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 3
ESPE DENTAL
  SUBSTANTIALLY EQUIVALENT 4
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 6
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 5
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 6
KULZER
  SUBSTANTIALLY EQUIVALENT 16
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 18

Device Problems
Improper or incorrect procedure or method 162
Loss of or failure to bond 94
No code available 43
Failure to Adhere or Bond 41
No Known Device Problem 35
Incorrect or inadequate result 27
Patient-device incompatibility 15
Use of Device Issue 11
Instruction for use issue 9
Bolus mechanism failure 5
Device handling issue 5
Contamination during use 5
Shelf life exceeded 4
No Information 1
Device Issue 1
Therapy delivered to incorrect body area 1
Unexpected therapeutic results 1
Material integrity issue 1
Total Device Problems 461

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

Recalls
Manufacturer Recall Class Date Posted
1 Heraeus Kulzer Inc., Dental Products Division III Oct-02-2007
2 Kerr Corporation III Mar-02-2012
3 Novocol, Inc. II Jul-29-2014
4 Sybron Dental Specialties II Mar-16-2010
5 Ultradent Products, Inc. II Jun-18-2012

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