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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 2
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 17

Device Problems
Improper or incorrect procedure or method 94
Loss of or failure to bond 45
Failure to Adhere or Bond 41
Incorrect or inadequate result 27
Bolus mechanism failure 5
Contamination during use 5
Device handling issue 3
Shelf life exceeded 2
Therapy delivered to incorrect body area 1
Total Device Problems 223

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 1 0 1 0
Class III 1 0 0 0 0 1 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 Sybron Dental Specialties II Mar-16-2010
4 Ultradent Products, Inc. II Jun-18-2012

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