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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device barrier, animal source, intraoral
Regulation Description Bone grafting material.
Definition An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.
Product CodeNPL
Regulation Number 872.3930
Device Class 2


Premarket Reviews
ManufacturerDecision
COLBAR LIFESCIENCE LTD.
  SUBSTANTIALLY EQUIVALENT 1
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 9
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 1
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 3
MATRICEL GMBH
  SUBSTANTIALLY EQUIVALENT 1
ORGANOGENESIS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 4
Total Device Problems 4

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

Recalls
Manufacturer Recall Class Date Posted
1 Kensey Nash Corp II May-17-2012

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