DEVICE CLASS
Class I
REGULATION
21 CFR 872.6640
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES
Recent clearances
K251626Midmark Corporation · 510k2025-11-03
K251491Osstem Implant Company., Ltd. Chair Business · 510k2025-07-17
K243130Guangdong Yadeng Medical Apparatus Co., Ltd., · 510k2025-06-27
K242611Mipont Medical Equipment Co., Ltd. · 510k2025-05-27
K250473Dci International, LLC · 510k2025-02-19
K242404Bdc Dental Corporation , Ltd. · 510k2025-02-07
K231297Firstar Dental Company · 510k2025-01-27
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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