← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
LYC — Bone Grafting Material, Synthetic
A synthetic bone grafting material is synthetically-derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal 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
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES
Recent clearances
K253317GC America, Inc. · 510k2026-07-06
K253883Bonalive , Ltd. · 510k2026-05-14
K251818Hudens Bio Co., Ltd. · 510k2026-03-06
K244006Full Golden Biotech Co., Ltd. · 510k2025-09-17
K243745Full Golden Biotech Corporation · 510k2025-08-29
K241186Shenzhen Dazhou Medical Technology Co., Ltd. · 510k2025-02-21
Related on SPEQ
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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