Ceramic Bracket— 510(k) K180952

Name: FDA 510(k) clearance K180952
Creator: U.S. Food and Drug Administration
Published: 2019-06-07

Substantially Equivalent

Mem Dental Technology Co., Ltd.

FDA 510(k) clearance K180952 for Ceramic Bracket, Substantially Equivalent on 2019-06-07. Applicant: Mem Dental Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Mem Dental Technology Co., Ltd.
Product code: Code NJM
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2018-04-11
Decision date: 2019-06-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tainan City, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.