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..
FDA 510(k) Cleared Barrier, Animal Source, Intraoral Devices (Product Code NPL)
About Product Code NPL - Regulatory Context
510(k) Submission Activity
57 total 510(k) submissions under product code NPL since 2001, with 57 receiving FDA clearance (average review time: 225 days).
Submission volume has remained relatively stable over the observed period, with 5 submissions in the last 24 months.
FDA 510(k) Review Time - NPL Product Code
FDA review times for NPL submissions have been consistent, averaging 205 days recently vs 227 days historically.
NPL devices are reviewed by the Dental panel. Browse all Dental devices →