|Trade Name||PEPGEN P-15 FLOW (FORMERLY PEPGEN P-15 PUTTY)|
|Classification Name||bone grafting material, dental, with biologic component|
|Generic Name||endosseous implant for bone filling and/or augmentation|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| 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.