Premium Plus C01/C02 LED Curing Light— 510(k) K153514

Name: FDA 510(k) clearance K153514
Creator: U.S. Food and Drug Administration
Published: 2016-08-22

Substantially Equivalent

Premium Plus International Limited

FDA 510(k) clearance K153514 for Premium Plus C01/C02 LED Curing Light, Substantially Equivalent on 2016-08-22. Applicant: Premium Plus International Limited. Device class: 2.

Clearance details

Applicant: Premium Plus International Limited
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2015-12-07
Decision date: 2016-08-22
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hong Kong, CN

Download summary PDF View on FDA.gov ↗

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