C&B NFH Hybrid— 510(k) K232559

Substantially Equivalent

Arum Dentistry Co., Ltd.

FDA 510(k) clearance K232559 for C&B NFH Hybrid, Substantially Equivalent on 2024-09-11. Applicant: Arum Dentistry Co., Ltd.. Device class: 2.

Clearance details

Applicant: Arum Dentistry Co., Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2023-08-23
Decision date: 2024-09-11
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.