• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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.
 
DevicePEPGEN P-15 FLOW (FORMERLY PEPGEN P-15 PUTTY)
Classification Namebone grafting material, dental, with biologic component
Generic Namebone grafting material, dental, with biologic component
Regulation Number872.3930
Applicant
CERAMED CORP.
12860 west cedar drive,
suite 108
lakewood, CO 80228
PMA NumberP990033
Supplement NumberS002
Date Received01/02/2001
Decision Date08/09/2001
Product Code
NPZ[ Registered Establishments with NPZ ]
Advisory Committee Dental
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to pepgen p-15 to form pepgen p-15 putty. The device, as modified, will be marketed under the trade name pepgen p-15 flow, but have the same indications for use as pepgen p-15.
-
-