Luce Ceramic Bracket— 510(k) K201038

Substantially Equivalent

Luce Castle Co., Ltd.

FDA 510(k) clearance K201038 for Luce Ceramic Bracket, Substantially Equivalent on 2020-10-09. Applicant: Luce Castle Co., Ltd.. Device class: 2.

Clearance details

Applicant: Luce Castle Co., Ltd.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2020-04-20
Decision date: 2020-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gyeonggi, 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.