LOOP LED Curing Light System (CLK01)— 510(k) K241238

Name: FDA 510(k) clearance K241238
Creator: U.S. Food and Drug Administration
Published: 2024-08-01

Substantially Equivalent

Garrison Dental Solutions, LLC

FDA 510(k) clearance K241238 for LOOP LED Curing Light System (CLK01), Substantially Equivalent on 2024-08-01. 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: 2024-05-03
Decision date: 2024-08-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spring Lake, MI, US

Download summary PDF View on FDA.gov ↗

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