LED Curing Light— 510(k) K150205

Substantially Equivalent

Monitex Industrial Co., Ltd.

FDA 510(k) clearance K150205 for LED Curing Light, Substantially Equivalent on 2015-08-24. 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: 2015-01-29
Decision date: 2015-08-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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More clearances from Monitex Industrial Co., Ltd.

K161855 — LED Curing Light2017-11-27
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K133040 — LED CURING LIGHT2014-10-07
K091887 — LED CURING LIGHT, MODEL GT-15002009-09-18

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