Light Cure Adhesive— 510(k) K241056

Name: FDA 510(k) clearance K241056
Creator: U.S. Food and Drug Administration
Published: 2024-07-16

Substantially Equivalent

Sincera Technology (Changchun) Co., Ltd.

FDA 510(k) clearance K241056 for Light Cure Adhesive, Substantially Equivalent on 2024-07-16. Applicant: Sincera Technology (Changchun) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sincera Technology (Changchun) Co., Ltd.
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2024-04-18
Decision date: 2024-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changchun, 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.