Dental Desensitizer— 510(k) K222891

Name: FDA 510(k) clearance K222891
Creator: U.S. Food and Drug Administration
Published: 2023-05-25

Substantially Equivalent

Guangzhou Beogene Biotech Co., Ltd.

FDA 510(k) clearance K222891 for Dental Desensitizer, Substantially Equivalent on 2023-05-25. Applicant: Guangzhou Beogene Biotech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Beogene Biotech Co., Ltd.
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2022-09-23
Decision date: 2023-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, 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.