Dental Lithium Disilicate Glass-Ceramic— 510(k) K230487

Name: FDA 510(k) clearance K230487
Creator: U.S. Food and Drug Administration
Published: 2023-07-03

Substantially Equivalent

Fuzhou Rick Brown Biomaterials Co., Ltd.

FDA 510(k) clearance K230487 for Dental Lithium Disilicate Glass-Ceramic, Substantially Equivalent on 2023-07-03. Applicant: Fuzhou Rick Brown Biomaterials Co., Ltd.. Device class: 2.

Clearance details

Applicant: Fuzhou Rick Brown Biomaterials Co., Ltd.
Product code: Code EIH
Device class: Class 2
Regulation: 21 CFR 872.6660
Advisory panel: Dental
Date received: 2023-02-23
Decision date: 2023-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fuzhou, CN

Download summary PDF View on FDA.gov ↗

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