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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device varnish, cavity
Regulation Description Cavity varnish.
Product CodeLBH
Regulation Number 872.3260
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 3
CAO GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 3
IVOCLAR VIVADENT, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SUNSTAR BUTLER
  SUBSTANTIALLY EQUIVALENT 1
ULTRADENT PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 8

Device Problems
Improper or incorrect procedure or method 46
Device operates differently than expected 28
Extrusion 25
No Known Device Problem 22
Patient-device incompatibility 10
Instruction for use issue 8
Use of Device Issue 5
Expulsion 5
No Information 4
Device handling issue 1
Not Applicable 1
Total Device Problems 155

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

Recalls
Manufacturer Recall Class Date Posted
1 Dharma Research, Inc. II Dec-01-2014
2 Discus Dental LLC II Nov-24-2014
3 Heraeus Kulzer, LLC. II May-23-2014

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