C&B 5.0 Hybrid— 510(k) K210817

Substantially Equivalent

Arum Dentistry Co., Ltd.

FDA 510(k) clearance K210817 for C&B 5.0 Hybrid, Substantially Equivalent on 2021-12-08. Applicant: Arum Dentistry Co., Ltd.. Device class: 2.

Clearance details

Applicant: Arum Dentistry Co., Ltd.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2021-03-18
Decision date: 2021-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Daejeon, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.