DEVICE CLASS
Class I
REGULATION
21 CFR 872.4200
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
K252223SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · 510k2025-10-16
K251597Perimetrics, Inc. · 510k2025-09-18
K243692Advanced Technology Research (A.T.R.) S.R.L. · 510k2025-08-22
K242514Shenzhen Rogin Medical Co., Ltd. · 510k2025-04-24
K241065Dentis Co., Ltd. · 510k2025-03-21
K243911Handpiece Headquarters · 510k2024-12-20
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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