DEVICE CLASS
Class II
REGULATION
21 CFR 872.6660
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
31
510(K)/PMA CLEARANCES
510k: 31
0
RECALL ENTRIES
Recent clearances
K261046Hunan Qinghao Puzhong Technology Co., Ltd. · 510k2026-07-17
K262195Zima International Inc., dba Dandy · 510k2026-06-30
K260918Amann Girrbach AG · 510k2026-06-29
K260859Hass Corp. · 510k2026-06-11
K253191Dental Creativ Management GmbH · 510k2026-05-21
K260067Shandong Huge Dental Material Corporation · 510k2026-04-09
K260370Bloomden Bioceramics (HuNan) Co., Ltd. · 510k2026-03-30
K253953Ivoclar Vivadent, Inc. · 510k2026-03-10
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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