LEDEX— 510(k) K131042

Substantially Equivalent

Dentmate Technology Co. , Ltd.

FDA 510(k) clearance K131042 for LEDEX, Substantially Equivalent on 2013-10-03. 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: 2013-04-15
Decision date: 2013-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei, TW

Download summary PDF View on FDA.gov ↗

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