DeviceClearance

Product code NPL— Dental

MUCOGRAFT

Classification name
Barrier, Animal Source, Intraoral
Device class
Class 2
Regulation
21 CFR 872.3930
Advisory panel
Dental
Total cleared
57
First cleared
Most recent

FDA classification definition

“An animal source dental barrier is an animal-derived material device, such as collagen, intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.”

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

Market context for product code NPL

FDA has cleared 57 devices under product code NPL between 2001 and 2025, filed by 32 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 NPL

Recent clearances under product code NPL

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