NPM · Class II · 21 CFR 872.3930

FDA Product Code NPM: Bone Grafting Material, Animal Source

Animal-derived bone grafting materials provide a natural scaffold for bone regeneration. FDA product code NPM covers animal-source bone grafting materials used in dental surgery.

These xenograft materials — typically derived from bovine or porcine bone — are processed to remove organic components while preserving the mineral scaffold, providing a biocompatible matrix that supports new bone formation in extraction sockets, sinus lifts, and periodontal defects.

NPM devices are Class II medical devices, regulated under 21 CFR 872.3930 and reviewed by the FDA Dental panel.

Leading manufacturers include Geistlich Pharma AG, Collagen Matrix, Inc. and Purgo Biologics, Inc..

42
Total
42
Cleared
228d
Avg days
2004
Since
42 devices
25–42 of 42
Cleared Dec 10, 2015
Regenomer® Syringe, Regenomer® Plug, Regenomer® Block
K150079
Nibec Co., Ltd.
Dental · 329d
Cleared Nov 06, 2015
InterOss
K151209
Sigmagraft, Inc.
Dental · 184d
Cleared Jul 31, 2015
OCS-B COLLAGEN
K142040
Nibec Co., Ltd.
Dental · 368d
Cleared Jun 05, 2015
TI-OSS
K140021
Chiyewon
Dental · 518d
Cleared Jul 16, 2014
PORCINE ANORGANIC BONE MINERAL
K140714
Collagen Matrix, Inc.
Dental · 117d
Cleared May 22, 2014
SYNERGY
K123876
Odontit S.A.
Dental · 521d
Cleared Feb 15, 2013
GEISTLICH BIO-OSS, GEISTLICH BIO-OSS COLLAGEN, GEISTLICH COMBI-KIT COLLAGEN, GEISTLICH PERIO SYSTEM COMBI PACK, GEISTLIC
K122894
Geistlich Pharma AG
Dental · 148d
Cleared Jan 16, 2013
OCS-B
K113246
Nibec Company, Limited
Dental · 441d
Cleared Aug 13, 2012
CERASORB PLUS
K120152
Riemser Arzneimittel AG
Dental · 208d
Cleared May 24, 2012
GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O
K120601
Geistlich Pharma AG
Dental · 86d
Cleared Dec 28, 2011
GEISTLICH COMBI-KIT COLLEGEN
K112572
Geistlich Pharma AG
Dental · 113d
Cleared Dec 27, 2011
GEISTLICH PERIO-SYSTEM COMBI-PACK , GEISTLICH BIO-GIDE PERIO
K112575
Geistlich Pharma AG
Dental · 112d
Cleared Sep 29, 2011
EQUIMATRIX
K111816
Luitpold Pharmaceuticals, Inc.
Dental · 94d
Cleared Aug 18, 2010
OSTA MAXIGRO AND REGIGRO
K091424
Osta Technologies
Dental · 462d
Cleared Mar 18, 2010
BIO-OSS COLLAGEN
K092428
Ed. Geistlich Soehne AG Fuer Chemische Industrie
Dental · 223d
Cleared Dec 10, 2009
OSTEOTAPE
K090794
Impladent , Ltd.
Dental · 261d
Cleared Aug 04, 2005
OSTEOGUIDE ANORGANIC BONE MINERAL PRODUCTS
K043034
Collagen Matrix, Inc.
Dental · 274d
Cleared Jan 15, 2004
BIO-OSS, BIO-OSS BLOCKS AND BIO-OSS COLLAGEN
K033815
Geistlich-Pharma
Dental · 37d