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
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
Jul 29, 2011
COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN
Collagen Matrix, Inc.
Dental
149d
Cleared
May 04, 2011
GENOSS COLLAGEN MEMBRANE MODEL GCM1020, GCM3040 TOTAL 6 MODELS
Genoss Co., Ltd.
Dental
261d
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
Oct 13, 2006
COLLAGEN DENTAL MEMBRANE III
Collagen Matrix, Inc.
Dental
21d
Cleared
Oct 11, 2006
COLLAGEN DENTAL MENBRANE - CONFORMABLE II
Collagen Matrix, Inc.
Dental
15d
Cleared
Aug 09, 2005
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE
Ed. Geistlich Soehne AG Fuer Chemische Industrie
Dental
168d
Cleared
Nov 15, 2004
BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION
Ed. Geistlich Soehne AG Fuer Chemische Industrie
Dental
94d
Cleared
Jun 10, 2002
SURGISIS GUIDED TISSUE REGENERATION MATRIX
Cook Biotech, Inc.
Dental
437d
Cleared
Aug 07, 2001
COLLAGEN DENTAL MEMBRANE
Collagen Matrix, Inc.
Dental
68d
Cleared
Jan 08, 2001
COLLAGEN PERIODONTAL MEMBRANE
Collagen Matrix, Inc.
Dental
75d