Apapro Desensitizer— 510(k) K220419

Substantially Equivalent

Sangi Co., Ltd.

FDA 510(k) clearance K220419 for Apapro Desensitizer, Substantially Equivalent on 2022-02-16. Applicant: Sangi Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sangi Co., Ltd.
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2022-02-14
Decision date: 2022-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.