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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device resin, root canal filling
Regulation Description Root canal filling resin.
Product CodeKIF
Regulation Number 872.3820
Device Class 2


Premarket Reviews
ManufacturerDecision
CONFI-DENTAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 1
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 2
HYGENIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 1
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SYBRON
  SUBSTANTIALLY EQUIVALENT 3
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Patient-device incompatibility 8
No Information 7
Material discolored 5
Overfill 5
Device operates differently than expected 1
No Known Device Problem 1
No code available 1
Total Device Problems 28

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

Recalls
Manufacturer Recall Class Date Posted
1 Ormco/Sybronendo II Sep-16-2016
2 Sybron Dental Specialties II Mar-02-2010

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