Pepgen P-15, Pepgen P-15 Flow & Pepgen P-15 Putty

• • Terminated Z-0579-05 FDA Unclassified (pre-2012) ·initiated 17 Feb 2005

  PepGen P-15 Putty kit was labeled with the incorrect expiration date.

Trade Name

Pepgen P-15

Generic Name

Bone grafting material, dental, with biologic component

PMA Number

P990033 ↗

FDA Product Code

NPZ

Device Class

Class III

Regulation

21 CFR Part 872.3930

Advisory Committee

Dental

FDA Decision

APWD Approval withdrawn

• Permamesh-D Hydroxylapatite Matrix

  Class II

  FDA 510(k) K960361 Active Cleared 15 Apr 1996

• Osteograf Stainless Steel Syring

  Class II

  FDA 510(k) K962786 Active Cleared 1 Aug 1996

• Permaridge Syringe

  Class II

  FDA 510(k) K962838 Active Cleared 20 Aug 1996

• Osteograf/Ld-300 Hydroxylapatite

  Class II

  FDA 510(k) K942212 Active Cleared 23 Aug 1994

• Osteograf/N Natural Hydroxylapatite, 40-60 Mesh

  Class II

  FDA 510(k) K902295 Active Cleared 11 Dec 1990

• Osteograf/N-700 Natural Hydroxylapatite 18-40 Mesh

  Class II

  FDA 510(k) K921469 Active Cleared 25 Jun 1992

See all devices from Ceramed Corp. →