DEVICE CLASS
Class II
REGULATION
21 CFR 872.3690
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
41
510(K)/PMA CLEARANCES
510k: 41
0
RECALL ENTRIES
Recent clearances
K262228Ultradent Products, Inc. · 510k2026-07-01
K261485Ivoclar Vivadent, Inc. · 510k2026-07-01
K261246GC America, Inc. · 510k2026-06-18
K261093DiaDent Group International · 510k2026-06-02
K261071DiaDent Group International · 510k2026-05-19
K260805Vericom Co., Ltd. · 510k2026-05-11
K261356Hangzhou SHINING3D Dental Technology Co., Ltd. · 510k2026-04-27
K261357Voco GmbH · 510k2026-04-27
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.