LEDEX, MODEL: WL-070— 510(k) K082408

Name: FDA 510(k) clearance K082408
Creator: U.S. Food and Drug Administration
Published: 2008-12-03

Substantially Equivalent

Dentmate Technology Co. , Ltd.

FDA 510(k) clearance K082408 for LEDEX, MODEL: WL-070, Substantially Equivalent on 2008-12-03. Applicant: Dentmate Technology Co. , Ltd.. Device class: 2.

Clearance details

Applicant: Dentmate Technology Co. , Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2008-08-21
Decision date: 2008-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sanchung, TW

Download summary PDF View on FDA.gov ↗

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