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
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
Jun 06, 2006
MUCOGRAFT
Ed. Geistlich Soehne AG Fuer Chemische Industrie
Dental
34d
Cleared
Feb 22, 2006
OSSIX -PLUS
Colbar Lifescience , Ltd.
Dental
92d
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
Jan 24, 2003
MUCOGRAFT
Ed. Geistlich Soehne AG Fuer Chemische Industrie
Dental
543d
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