Light Cure Dental Adhesive— 510(k) K201787

Name: FDA 510(k) clearance K201787
Creator: U.S. Food and Drug Administration
Published: 2020-09-25

Substantially Equivalent

Rizhao Huge Biomaterials Company, Ltd.

FDA 510(k) clearance K201787 for Light Cure Dental Adhesive, Substantially Equivalent on 2020-09-25. Applicant: Rizhao Huge Biomaterials Company, Ltd.. Device class: 2.

Clearance details

Applicant: Rizhao Huge Biomaterials Company, Ltd.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2020-06-30
Decision date: 2020-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao City, CN

Download summary PDF View on FDA.gov ↗

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