|
Device | PEPGEN P-15, PEPGEN P-15 FLOW & PEPGEN P-15 PUTTY |
Generic Name | Bone grafting material, dental, with biologic component |
Regulation Number | 872.3930 |
Applicant | CERAMED CORP. 12860 WEST CEDAR DRIVE, SUITE 108 LAKEWOOD, CO 80228 |
PMA Number | P990033 |
Supplement Number | S014 |
Date Received | 01/16/2007 |
Decision Date | 08/09/2007 |
Withdrawal Date
|
02/16/2016 |
Product Code |
NPZ |
Advisory Committee |
Dental |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO RELOCATE THE MANUFACTURING SITE TO DENTSPLY SPECIALTY MATERIALS LOCATED IN YORK PENNSYLVANIA. |