Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
Trade NamePEPGEN P-15, PEPGEN P-15 FLOW, AND PEPGEN P-15 PUTTY
Classification Namebone grafting material, dental, with biologic component
Generic Nameendosseous implant for bone filling and/or augmentation
Regulation Number872.3930
ApplicantDENTSPLY CERAMED DENTAL
PMA NumberP990033
Supplement NumberS005
Date Received11/12/2003
Decision Date03/15/2004
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) the addition of a paste form of pepgen p-15, 2) modification of the device labeling for all pepgen p-15 devices, and 3) changing of the contract manufacturer for the device carrier to hyaluron, inc. , woburn, massachusetts.
-
-