DEVICE CLASS
Class II
REGULATION
21 CFR 872.1800
MEDICAL SPECIALTY
Dental
REVIEW PANEL
RA
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
6
510(K)/PMA CLEARANCES
510k: 6
0
RECALL ENTRIES
Recent clearances
K251793Sota Cloud Corp. · 510k2026-03-03
K252570Qpix Solutions, Inc. · 510k2025-11-10
K250687Dexcowin Global, Inc. · 510k2025-10-24
K251206Dentimax, Inc. · 510k2025-09-24
K240040VATECH Co., Ltd. · 510k2024-10-25
K242778Qpix Solutions, Inc. · 510k2024-10-11
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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