CuringPen Dental Curing Light— 510(k) K221152

Name: FDA 510(k) clearance K221152
Creator: U.S. Food and Drug Administration
Published: 2022-11-23

Substantially Equivalent

Changzhou Sifary Medical Technology Co., Ltd.

FDA 510(k) clearance K221152 for CuringPen Dental Curing Light, Substantially Equivalent on 2022-11-23. Applicant: Changzhou Sifary Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Changzhou Sifary Medical Technology Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2022-04-20
Decision date: 2022-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changzhou, 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.