← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

ELC — Scaler, Ultrasonic

DEVICE CLASS
Class II
REGULATION
21 CFR 872.4850
MEDICAL SPECIALTY
Dental
REVIEW PANEL
DE
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
4
510(K)/PMA CLEARANCES
510k: 4
0
RECALL ENTRIES

Recent clearances

K260773Nakanishi, Inc. · 510k2026-03-10
K253254E.M.S Electro Medical Systems S.A · 510k2026-01-28
K251689Nakanishi, Inc. · 510k2025-09-19
K242317Denjoy Dental Co., Ltd. · 510k2025-02-13

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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