LED Curing Light— 510(k) K161855

Substantially Equivalent

Monitex Industrial Co., Ltd.

FDA 510(k) clearance K161855 for LED Curing Light, Substantially Equivalent on 2017-11-27. 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: 2016-07-06
Decision date: 2017-11-27
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.

K152192 — LED Curing Light2017-04-07
K153078 — LED Curing Light GT-20002016-06-28
K150205 — LED Curing Light2015-08-24
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.