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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material
Regulation Number872.3930
PMA NumberP040013
Supplement NumberS009
Date Received12/22/2006
Decision Date08/10/2007
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the new reference standard, which is used in the following analytical methods: rp-hplc, sec, sds-page, uv, bioassay, elisa, and phh.
Post-Approval StudyShow Report Schedule and Study Progress