← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

EBI — Resin, Denture, Relining, Repairing, Rebasing

DEVICE CLASS
Class II
REGULATION
21 CFR 872.3760
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
19
510(K)/PMA CLEARANCES
510k: 19
0
RECALL ENTRIES

Recent clearances

K262300Formlabs Ohio, Inc. · 510k2026-07-08
K261474Dentca, Inc. · 510k2026-07-01
K260569Carbon, Inc. · 510k2026-06-02
K260376Shandong Huge Dental Material Corporation · 510k2026-05-06
K253365LuxCreo, Inc. · 510k2025-11-25
K253681Graphy, Inc. · 510k2025-11-21
K253324Guangzhou Heygears IMC., Inc. · 510k2025-11-20
K252430Detax GmbH · 510k2025-10-30

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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