U-Cem Premium & MAZIC Cem— 510(k) K193260

Substantially Equivalent

Vericom Co., Ltd.

FDA 510(k) clearance K193260 for U-Cem Premium & MAZIC Cem, Substantially Equivalent on 2020-08-21. Applicant: Vericom Co., Ltd.. Device class: 2.

Clearance details

Applicant: Vericom Co., Ltd.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2019-11-26
Decision date: 2020-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chuncheon-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.