Aidite PMMA— 510(k) K190217

Name: FDA 510(k) clearance K190217
Creator: U.S. Food and Drug Administration
Published: 2020-12-17

Substantially Equivalent

Aidite (Qinhuangdao) Technology Co., Ltd.

FDA 510(k) clearance K190217 for Aidite PMMA, Substantially Equivalent on 2020-12-17. Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2019-02-04
Decision date: 2020-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qinhuangdao, CN

Download summary PDF View on FDA.gov ↗

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