iCTmotor (WL-1)— 510(k) K193341

Substantially Equivalent

Dentium Co., Ltd.

FDA 510(k) clearance K193341 for iCTmotor (WL-1), Substantially Equivalent on 2020-09-04. Applicant: Dentium Co., Ltd.. Device class: 1.

Clearance details

Applicant: Dentium Co., Ltd.
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2019-12-03
Decision date: 2020-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suwon-Si, 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.