DEVICE CLASS
Class I
REGULATION
21 CFR 872.4200
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
K251388Foshan Topmed Dental Co., Ltd. · 510k2026-01-12
K251389Foshan Topmed Dental Co., Ltd. · 510k2026-01-12
K242179W&H Dentalwerk Bürmoos GmbH · 510k2025-02-28
K240337Guangdong Jinme Medical Technology Co., Ltd. · 510k2024-11-13
K241074Foshan Soco Precision Instrument Co., Ltd. · 510k2024-11-12
K241880Nakanishi, Inc. · 510k2024-09-20
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.