← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

ELW — Material, Impression

DEVICE CLASS
Class II
REGULATION
21 CFR 872.3660
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
5
510(K)/PMA CLEARANCES
510k: 5
0
RECALL ENTRIES

Recent clearances

K254112DiaDent Group International · 510k2026-03-19
K253501Vigodent Indústria E Comercio Ltda · 510k2025-10-31
K250969Dent4you AG · 510k2025-06-27
K241924Beijing Okvd Biological Technology , Ltd. · 510k2024-12-27
K242360Dent4you AG · 510k2024-11-15

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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