Light Cure Composite— 510(k) K240112

Name: FDA 510(k) clearance K240112
Creator: U.S. Food and Drug Administration
Published: 2024-03-15

Substantially Equivalent

Sincera Technology (Changchun) Co., Ltd.

FDA 510(k) clearance K240112 for Light Cure Composite, Substantially Equivalent on 2024-03-15. Applicant: Sincera Technology (Changchun) Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sincera Technology (Changchun) Co., Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2024-01-16
Decision date: 2024-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changchun, CN

Download summary PDF View on FDA.gov ↗

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K261246 — SRGC-062026-06-18

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K241056 — Light Cure Adhesive2024-07-16

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