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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bone grafting material, animal source
Regulation Description Bone grafting material.
Definition A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.
Product CodeNPM
Regulation Number 872.3930
Device Class 2


Premarket Reviews
ManufacturerDecision
COLLAGEN MATRIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
GEISTLICH PHARMA AG
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
Device Issue 1
Total Device Problems 1

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 0 2
Class III 0 0 0 0 0 0 0 0 0 1

Recalls
Manufacturer Recall Class Date Posted
1 Collagen Matrix Inc III Mar-15-2016
2 Collagen Matrix Inc II Mar-11-2016
3 Collagen Matrix Inc II Mar-11-2016

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