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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device biologic material, dental
Regulation Description Bone grafting material.
Definition Other dental material with growth factors is a material, used with or without other devices, 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 CodeNQA
Regulation Number 872.3930
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
1 0 2 0 0 0 1 0 4 0

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