TopCEM-Veneer Light Cure Veneer Cement— 510(k) K241204

Name: FDA 510(k) clearance K241204
Creator: U.S. Food and Drug Administration
Published: 2024-06-28

Substantially Equivalent

Rizhao Huge Biomaterials Company, Ltd.

FDA 510(k) clearance K241204 for TopCEM-Veneer Light Cure Veneer Cement, Substantially Equivalent on 2024-06-28. Applicant: Rizhao Huge Biomaterials Company, Ltd.. Device class: 2.

Clearance details

Applicant: Rizhao Huge Biomaterials Company, Ltd.
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2024-04-30
Decision date: 2024-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao, 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.