Dental Glass Ceramics Blocks (HT, LT, MT)— 510(k) K242407

Name: FDA 510(k) clearance K242407
Creator: U.S. Food and Drug Administration
Published: 2024-11-13

Substantially Equivalent

Hunan Vsmile Biotechnology Co., Ltd.

FDA 510(k) clearance K242407 for Dental Glass Ceramics Blocks (HT, LT, MT), Substantially Equivalent on 2024-11-13. 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: 2024-08-14
Decision date: 2024-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hi-Tech Development District Changsha, CN

Download summary PDF View on FDA.gov ↗

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