NPL · Class II · 21 CFR 872.3930

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
25–48 of 58
Cleared Aug 04, 2016
OSSIX PLUS
K160281
Datum Dental, Ltd.
Dental · 184d
Cleared Jun 07, 2016
DSM Biomedical Porcine Pericardium Dental Membrane
K160474
Kensey Nash Corporation Dba Dsm Biomedical
Dental · 109d
Cleared Sep 15, 2015
VITALA PORCINE DERIVED COLLAGEN MEMBRANE
K141177
Osteogenics Biomedical, Inc. (Formerly Obi Biologi
Dental · 496d
Cleared Nov 24, 2014
Collagen Dental Membrane - Conformable IIBP
K142496
Collagen Matrix, Inc.
Dental · 80d
Cleared Nov 05, 2014
GUIDOSS
K133507
Nibec Co., Ltd.
Dental · 356d
Cleared Nov 05, 2014
COLLAGEN DENTAL MEMBRANE - CONFORMABLE PP
K141909
Collagen Matrix, Inc.
Dental · 113d
Cleared Jul 18, 2014
GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
K140518
Geistlich Pharma AG
Dental · 140d
Cleared Feb 24, 2014
MATRICEL DENTAL BARRIER MEMBRANE
K123697
Matricel GmbH
Dental · 448d
Cleared Jul 11, 2013
MESOTHELIUM DENTAL MEMBRANE
K121310
Kensey Nash Corporation
Dental · 436d
Cleared Jan 03, 2013
COLLADENTAL BARRIER
K100695
Collamatrix, Inc.
Dental · 1029d
Cleared Aug 26, 2011
COVAMAX RESORBABLE COLLAGEN MEMBRANE
K103087
Biom'Up Sas
Dental · 311d
Cleared Jul 29, 2011
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
K110600
Collagen Matrix, Inc.
Dental · 149d
Cleared Jul 21, 2011
VITALA NATURAL RESORBABLE COLLAGEN MEMBRANE
K101453
Obi Biologics, Inc.
Dental · 422d
Cleared May 04, 2011
GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
K102307
Genoss Co., Ltd.
Dental · 261d
Cleared Nov 17, 2010
MUCOGRAFT
K102531
Ed. Geistlich Soehne AG Fur Chemische Industrie
Dental · 75d
Cleared Aug 11, 2010
COLLAGEN DENTAL MEMBRANE V
K100156
Collagen Matrix, Inc.
Dental · 203d
Cleared Nov 02, 2009
KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX
K091192
Kensey Nash Corp.
Dental · 193d
Cleared Oct 02, 2009
KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANE
K090919
Kensey Nash Corp.
Dental · 184d
Cleared Sep 18, 2009
COLLAGEN DENTAL MEMBRANE IV
K090216
Collagen Matrix, Inc.
Dental · 232d
Cleared Oct 02, 2008
DYNAMATRIX
K082058
Cook Biotech, Inc.
Dental · 73d
Cleared Aug 29, 2008
OTA COLLAGEN BIOMATERIAL
K073685
Osseous Technologies of America
Dental · 245d
Cleared May 30, 2008
MUCOGRAFT COLLAGEN MATRIX
K073711
Ed. Geistlich Soehne AG Fuer Chemische Industrie
Dental · 151d
Cleared May 12, 2008
TUTODENT DENTAL MEMBRANE
K073097
Tutogen Medical U.S., Inc.
Dental · 193d
Cleared Aug 30, 2007
FORTAGEN ORAL MEMBRANE
K071555
Organogenesis, Inc.
Dental · 84d