DeviceClearance

Product code NPM— Dental

A-Oss

Classification name
Bone Grafting Material, Animal Source
Device class
Class 2
Regulation
21 CFR 872.3930
Advisory panel
Dental
Total cleared
40
First cleared
Most recent

FDA classification definition

“A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.”

— U.S. Food and Drug Administration, device classification record for product code NPM under 21 CFR 872.3930, via openFDA

Market context for product code NPM

FDA has cleared 40 devices under product code NPM between 2004 and 2026, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code NPM

Recent clearances under product code NPM

Data sourced from openFDA. This site is unofficial and independent of the FDA.