FDA Product Code NPL: Barrier, Animal Source, Intraoral
FDA product code NPL covers animal-derived intraoral barriers used in dental procedures.
These natural membrane materials — typically derived from bovine or porcine collagen — are used as resorbable barriers in guided bone regeneration and guided tissue regeneration procedures. They separate epithelial tissue from bone defects, allowing selective repopulation by osteogenic cells.
NPL devices are Class II medical devices, regulated under 21 CFR 872.3930 and reviewed by the FDA Dental panel.
Leading manufacturers include Collagen Matrix, Inc., Geistlich Pharma AG and Ed. Geistlich Soehne AG Fuer Chemische Industrie.
58
Total
58
Cleared
223d
Avg days
2001
Since
58 devices
Cleared
Aug 04, 2016
OSSIX PLUS
Datum Dental, Ltd.
Dental
184d
Cleared
Jun 07, 2016
DSM Biomedical Porcine Pericardium Dental Membrane
Kensey Nash Corporation Dba Dsm Biomedical
Dental
109d
Cleared
Sep 15, 2015
VITALA PORCINE DERIVED COLLAGEN MEMBRANE
Osteogenics Biomedical, Inc. (Formerly Obi Biologi
Dental
496d
Cleared
Nov 24, 2014
Collagen Dental Membrane - Conformable IIBP
Collagen Matrix, Inc.
Dental
80d
Cleared
Nov 05, 2014
GUIDOSS
Nibec Co., Ltd.
Dental
356d
Cleared
Nov 05, 2014
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP
Collagen Matrix, Inc.
Dental
113d
Cleared
Jul 18, 2014
GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
Geistlich Pharma AG
Dental
140d
Cleared
Feb 24, 2014
MATRICEL DENTAL BARRIER MEMBRANE
Matricel GmbH
Dental
448d
Cleared
Jul 11, 2013
MESOTHELIUM DENTAL MEMBRANE
Kensey Nash Corporation
Dental
436d
Cleared
Jan 03, 2013
COLLADENTAL BARRIER
Collamatrix, Inc.
Dental
1029d
Cleared
Aug 26, 2011
COVAMAX RESORBABLE COLLAGEN MEMBRANE
Biom'Up Sas
Dental
311d
Cleared
Jul 29, 2011
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
Collagen Matrix, Inc.
Dental
149d
Cleared
Jul 21, 2011
VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
Obi Biologics, Inc.
Dental
422d
Cleared
May 04, 2011
GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
Genoss Co., Ltd.
Dental
261d
Cleared
Nov 17, 2010
MUCOGRAFT
Ed. Geistlich Soehne AG Fur Chemische Industrie
Dental
75d
Cleared
Aug 11, 2010
COLLAGEN DENTAL MEMBRANE V
Collagen Matrix, Inc.
Dental
203d
Cleared
Nov 02, 2009
KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX
Kensey Nash Corp.
Dental
193d
Cleared
Oct 02, 2009
KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE
Kensey Nash Corp.
Dental
184d
Cleared
Sep 18, 2009
COLLAGEN DENTAL MEMBRANE IV
Collagen Matrix, Inc.
Dental
232d
Cleared
Oct 02, 2008
DYNAMATRIX
Cook Biotech, Inc.
Dental
73d
Cleared
Aug 29, 2008
OTA COLLAGEN BIOMATERIAL
Osseous Technologies of America
Dental
245d
Cleared
May 30, 2008
MUCOGRAFT COLLAGEN MATRIX
Ed. Geistlich Soehne AG Fuer Chemische Industrie
Dental
151d
Cleared
May 12, 2008
TUTODENT DENTAL MEMBRANE
Tutogen Medical U.S., Inc.
Dental
193d
Cleared
Aug 30, 2007
FORTAGEN ORAL MEMBRANE
Organogenesis, Inc.
Dental
84d