Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank— 510(k) K221242

Name: FDA 510(k) clearance K221242
Creator: U.S. Food and Drug Administration
Published: 2022-07-29

Substantially Equivalent

Hunan Vsmile Biotechnology Co., Ltd.

FDA 510(k) clearance K221242 for Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Substantially Equivalent on 2022-07-29. Applicant: Hunan Vsmile Biotechnology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Hunan Vsmile Biotechnology Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2022-05-02
Decision date: 2022-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, CN

Download summary PDF View on FDA.gov ↗

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