Phosphoric Acid Etching Gel— 510(k) K221450

Name: FDA 510(k) clearance K221450
Creator: U.S. Food and Drug Administration
Published: 2022-09-12

Substantially Equivalent

Rizhao Huge Biomaterials Company, Ltd.

FDA 510(k) clearance K221450 for Phosphoric Acid Etching Gel, Substantially Equivalent on 2022-09-12. 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: 2022-05-18
Decision date: 2022-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao City, 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.