Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia— 510(k) K192535

Name: FDA 510(k) clearance K192535
Creator: U.S. Food and Drug Administration
Published: 2020-01-31

Substantially Equivalent

Qinhuangdao Audental Metal Technology Co., Ltd.

FDA 510(k) clearance K192535 for Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia, Substantially Equivalent on 2020-01-31. Applicant: Qinhuangdao Audental Metal Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Qinhuangdao Audental Metal Technology Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2019-09-16
Decision date: 2020-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qinhuangdao, CN

Download summary PDF View on FDA.gov ↗

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