Mei Ceramic Bracket— 510(k) K190608

Substantially Equivalent

Orthosun Co., Ltd.

FDA 510(k) clearance K190608 for Mei Ceramic Bracket, Substantially Equivalent on 2019-11-04. Applicant: Orthosun Co., Ltd.. Device class: 2.

Clearance details

Applicant: Orthosun Co., Ltd.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2019-03-11
Decision date: 2019-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Incheon, 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.