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 has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePEPGEN P-15
Classification Namebone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantCERAMED CORP.
PMA NumberP990033
Date Received06/24/1999
Decision Date10/25/1999
Product Code
NPZ[ Registered Establishments with NPZ ]
Docket Number 99M-4692
Notice Date 11/04/1999
Advisory Committee Dental
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for pepgen p-15. This device is intended to be used for intrabony periodontal osseous defects due to moderate or severe peridontitis.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S007 
S008 S014 S015 S016 S017 
-
-