Cleared Traditional

LOOP? LED Curing Light System (CLK01)

K241238 · Garrison Dental Solutions, LLC · Dental

Aug 2024

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K241238 is an FDA 510(k) clearance for the LOOP? LED Curing Light System (CLK01), a Activator, Ultraviolet, For Polymerization (Class II — Special Controls, product code EBZ), submitted by Garrison Dental Solutions, LLC (Spring Lake, US). The FDA issued a Cleared decision on August 1, 2024, 90 days after receiving the submission on May 3, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.6070.

Submission Details

510(k) Number	K241238 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2024
Decision Date	August 01, 2024
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF