Curing Light, Model: MaxCure 9— 510(k) K223414

Name: FDA 510(k) clearance K223414
Creator: U.S. Food and Drug Administration
Published: 2023-11-15

Substantially Equivalent

Guilin Refine Medical Instrument Co., Ltd.

FDA 510(k) clearance K223414 for Curing Light, Model: MaxCure 9, Substantially Equivalent on 2023-11-15. Applicant: Guilin Refine Medical Instrument Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guilin Refine Medical Instrument Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2022-11-10
Decision date: 2023-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guilin, 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.