TrusFIL Universal Composite Restorative— 510(k) K202063

Name: FDA 510(k) clearance K202063
Creator: U.S. Food and Drug Administration
Published: 2021-10-06

Substantially Equivalent

Rizhao Huge Biomaterials Company, Ltd.

FDA 510(k) clearance K202063 for TrusFIL Universal Composite Restorative, Substantially Equivalent on 2021-10-06. Applicant: Rizhao Huge Biomaterials Company, Ltd.. Device class: 2.

Clearance details

Applicant: Rizhao Huge Biomaterials Company, Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2020-07-27
Decision date: 2021-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao City, CN

Download summary PDF View on FDA.gov ↗

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