D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000— 510(k) K121093

Name: FDA 510(k) clearance K121093
Creator: U.S. Food and Drug Administration
Published: 2012-11-27

Substantially Equivalent

Dxm Co., Ltd.

FDA 510(k) clearance K121093 for D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000, Substantially Equivalent on 2012-11-27. Applicant: Dxm Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dxm Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2012-04-10
Decision date: 2012-11-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Great Neck, NY, US

Download summary PDF View on FDA.gov ↗

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