LED CURING LIGHT— 510(k) K080035

Substantially Equivalent

Monitex Industrial Co., Ltd.

FDA 510(k) clearance K080035 for LED CURING LIGHT, Substantially Equivalent on 2008-03-03. Applicant: Monitex Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Monitex Industrial Co., Ltd.
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2008-01-07
Decision date: 2008-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San-Chung City, 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.