DEVICE CLASS
Class II
REGULATION
21 CFR 872.3200
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
12
510(K)/PMA CLEARANCES
510k: 12
0
RECALL ENTRIES
Recent clearances
K260485Mediclus Co., Ltd. · 510k2026-05-14
K260430Belport Company, Inc., Gingi-Pak · 510k2026-04-10
K252450Ivoclar Vivadent, Inc. · 510k2026-03-05
K260682Premier Dental Products Company · 510k2026-03-03
K251587Vita Zahnfabrik H. Rauter GmbH & Co. Kg. · 510k2026-02-23
K252151Saremco Dental AG · 510k2025-12-05
K252469Dmp Dental Industry S.A. · 510k2025-11-06
K251124GC America, Inc. · 510k2025-10-02
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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