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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device sealant, pit and fissure, and conditioner
Regulation Description Pit and fissure sealant and conditioner.
Product CodeEBC
Regulation Number 872.3765
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONFI-DENTAL PRODUCTS CO.
  SUBSTANTIALLY EQUIVALENT 4
DENTSPLY TULSA DENTAL SPECIALTIES
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 3
KERR CORP.
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Use of Device Issue 8
Loss of or failure to bond 2
Shelf life exceeded 2
Total Device Problems 12

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

Recalls
Manufacturer Recall Class Date Posted
1 Ivoclar A. G. II Nov-04-2015
2 Ivoclar Vivadent, Inc. II Feb-29-2016

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