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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dam, rubber
Regulation Description Rubber dam and accessories.
Product CodeEIE
Regulation Number 872.6300
Device Class 1


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
HYGENIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 3
Patient-device incompatibility 2
Normal 1
Improper or incorrect procedure or method 1
Total Device Problems 7

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Coltene Whaledent Inc II Aug-06-2014

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