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 Geistlich Pharma AG, Aroa Biosurgery , Ltd. and Beijing Biosis Healing Biolog Ical Technology Co., 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 declined in recent years - 5 submissions in the last 24 months compared to 7 in the prior period.
FDA Review Time
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 →