DEVICE CLASS
Class II
REGULATION
21 CFR 872.4760
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
✓ Implant— Life-sustaining— GMP-exempt— Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES
Recent clearances
K252246Jeil Medical Corporation · 510k2026-04-02
K253373Southern Medical (Pty) , Ltd. · 510k2025-12-19
K251441Inion OY · 510k2025-11-07
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.