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 Datum Dental, Ltd..

57
Total
57
Cleared
225d
Avg days
2001
Since
57 devices
25–48 of 57
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 Jul 29, 2011
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
K110600
Collagen Matrix, Inc.
Dental · 149d
Cleared May 04, 2011
GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
K102307
Genoss Co., Ltd.
Dental · 261d
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 Oct 13, 2006
COLLAGEN DENTAL MEMBRANE III
K062846
Collagen Matrix, Inc.
Dental · 21d
Cleared Oct 11, 2006
COLLAGEN DENTAL MENBRANE - CONFORMABLE II
K062881
Collagen Matrix, Inc.
Dental · 15d
Cleared Aug 09, 2005
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
K050446
Ed. Geistlich Soehne AG Fuer Chemische Industrie
Dental · 168d
Cleared Nov 15, 2004
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION
K042197
Ed. Geistlich Soehne AG Fuer Chemische Industrie
Dental · 94d
Cleared Jun 10, 2002
SURGISIS GUIDED TISSUE REGENERATION MATRIX
K010952
Cook Biotech, Inc.
Dental · 437d
Cleared Aug 07, 2001
COLLAGEN DENTAL MEMBRANE
K011695
Collagen Matrix, Inc.
Dental · 68d
Cleared Jan 08, 2001
COLLAGEN PERIODONTAL MEMBRANE
K003339
Collagen Matrix, Inc.
Dental · 75d