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FDA PRODUCT CODE · CLASS II

NPM — Bone Grafting Material, Animal Source

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 872.3930
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K253723Medpark Co., Ltd. · 510k2026-06-16
K251786Geistlich Pharma AG · 510k2025-07-11
K251613Geistlich Pharma AG · 510k2025-06-26
K242510Geistlich Pharma AG · 510k2025-03-07

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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