FDA Product Code NPM: Bone Grafting Material, Animal Source
Animal-derived bone grafting materials provide a natural scaffold for bone regeneration. FDA product code NPM covers animal-source bone grafting materials used in dental surgery.
These xenograft materials — typically derived from bovine or porcine bone — are processed to remove organic components while preserving the mineral scaffold, providing a biocompatible matrix that supports new bone formation in extraction sockets, sinus lifts, and periodontal defects.
NPM 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, Collagen Matrix, Inc. and Purgo Biologics, Inc..
FDA 510(k) Cleared Bone Grafting Material, Animal Source Devices (Product Code NPM)
About Product Code NPM - Regulatory Context
510(k) Submission Activity
39 total 510(k) submissions under product code NPM since 2004, with 39 receiving FDA clearance (average review time: 227 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under NPM have taken an average of 188 days to reach a decision - down from 234 days historically, suggesting improved FDA processing for this classification.
NPM devices are reviewed by the Dental panel. Browse all Dental devices →