← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

EMA — Cement, Dental

DEVICE CLASS
Class II
REGULATION
21 CFR 872.3275
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
14
510(K)/PMA CLEARANCES
510k: 14
0
RECALL ENTRIES

Recent clearances

K261166DiaDent Group International · 510k2026-07-09
K254109GC America, Inc. · 510k2026-05-18
K253337Inter-Med, Inc. · 510k2026-04-15
K252606Voco GmbH · 510k2026-03-20
K254063Kulzer, LLC · 510k2025-12-19
K252785Rizhao Huge Biomaterials Company, Ltd. · 510k2025-12-12
K252808Shofu Dental Corporation · 510k2025-12-09
K252165Shofu Dental Corporation · 510k2025-10-28

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

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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