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.
FDA 510(k) Cleared Barrier, Animal Source, Intraoral Devices (Product Code NPL)
About Product Code NPL - Regulatory Context
510(k) Submission Activity
58 total 510(k) submissions under product code NPL since 2001, with 58 receiving FDA clearance (average review time: 223 days).
Submission volume has remained relatively stable over the observed period, with 6 submissions in the last 24 months.
FDA 510(k) Review Time - NPL Product Code
Recent submissions under NPL have taken an average of 188 days to reach a decision - down from 227 days historically, suggesting improved FDA processing for this classification.
NPL devices are reviewed by the Dental panel. Browse all Dental devices →