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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, dental, with biologic component
Regulation Description Bone grafting material.
Definition Dental bone grafting material with growth factors is a combination product which consists of a bone grafting material which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region.
Product CodeNPZ
Regulation Number 872.3930
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
5 10 5 4 4 6 6 3 1 1

Device Problems
No Known Device Problem 19
Not Applicable 3
Migration of device or device component 2
No code available 1
Total Device Problems 25

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 0
Class III 0 0 0 0 0 0 0 0 0 0


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