DEVICE CLASS
Class II
REGULATION
21 CFR 872.4880
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
K250123Hager& Meisinger GmbH · 510k2025-09-29
K251569Osstem Implant Co., Ltd. · 510k2025-08-13
K243190Ustomed Instrumente Ulrich Storz GmbH & Co. KG · 510k2025-06-27
K233419Proimtech Saglik Urunleri Anonim Sirketi · 510k2025-01-03
K240321Hager& Meisinger GmbH · 510k2024-10-17
K233721KLS-Martin L.P. · 510k2024-09-17
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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