LOOP LED Curing Light System— 510(k) K200775

Name: FDA 510(k) clearance K200775
Creator: U.S. Food and Drug Administration
Published: 2020-08-14

Substantially Equivalent

Garrison Dental Solutions, LLC

FDA 510(k) clearance K200775 for LOOP LED Curing Light System, Substantially Equivalent on 2020-08-14. Applicant: Garrison Dental Solutions, LLC. Device class: 2.

Clearance details

Applicant: Garrison Dental Solutions, LLC
Product code: Code EBZ
Device class: Class 2
Regulation: 21 CFR 872.6070
Advisory panel: Dental
Date received: 2020-03-25
Decision date: 2020-08-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spring Lake, MI, US

Download summary PDF View on FDA.gov ↗

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