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) | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePEPGEN P-15, PEPGEN P-15 FLOW & PEPGEN P-15 PUTTY
Generic NameBone grafting material, dental, with biologic component
Regulation Number872.3930
ApplicantCeramed Corp.
12860 W. Cedar Dr.,
Suite 108
Lakewood, CO 80228
PMA NumberP990033
Supplement NumberS014
Date Received01/16/2007
Decision Date08/09/2007
Withdrawal Date02/16/2016
Product Code NPZ 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO RELOCATE THE MANUFACTURING SITE TO DENTSPLY SPECIALTY MATERIALS LOCATED IN YORK PENNSYLVANIA.
-
-