← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

NPL — Barrier, Animal Source, Intraoral

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 872.3930
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K242817Botiss Biomaterials GmbH · 510k2025-12-12
K250512Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. · 510k2025-12-05
K252253Geistlich Pharma AG · 510k2025-11-25
K251062Geistlich Pharma AG · 510k2025-08-14
K250833Geistlich Pharma AG · 510k2025-04-15

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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