DEVICE CLASS
Class II
REGULATION
21 CFR 872.3770
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
8
510(K)/PMA CLEARANCES
510k: 8
0
RECALL ENTRIES
Recent clearances
K261261Hangzhou SHINING3D Dental Technology Co., Ltd. · 510k2026-04-17
K253380Liaoning Upcera Co., Ltd. · 510k2026-03-02
K251271Rizhao Huge Biomaterials Company, Ltd. · 510k2025-06-23
K243370Asiga Pty, Ltd. · 510k2025-05-05
K243621Evoden Indústria Comércio Importação E Exportação · 510k2025-04-22
K243951Taiwan Dental Materials Co., Ltd. · 510k2025-02-21
K231859Dentscare Ltda · 510k2024-11-26
K242559Sprintray, Inc. · 510k2024-11-26
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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