DEVICE CLASS
Class II
REGULATION
21 CFR 872.3260
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES
Recent clearances
K253052Nagy Oral Technology Qinhuangdao Co., Ltd. · 510k2026-06-11
K252073Voco GmbH · 510k2026-05-01
K261404Ultradent Products, Inc. · 510k2026-04-30
K260830Sangi Co., Ltd. · 510k2026-03-18
K250714Centrix, Inc. · 510k2025-11-21
K243777Theodent, LLC · 510k2025-05-27
K241489Inter-Med, Inc. · 510k2025-01-08
K241568GreenMark Biomedical, Inc. · 510k2025-01-02
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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