LED Curing Light GT-2000— 510(k) K153078

Name: FDA 510(k) clearance K153078
Creator: U.S. Food and Drug Administration
Published: 2016-06-28

Substantially Equivalent

Monitex Industrial Co., Ltd.

FDA 510(k) clearance K153078 for LED Curing Light GT-2000, Substantially Equivalent on 2016-06-28. 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: 2015-10-23
Decision date: 2016-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei 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.