Cleared Traditional

K241238 - LOOP™ LED Curing Light System (CLK01) (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K241238 · Garrison Dental Solutions, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
90d
Days
Class 2
Risk

K241238 is an FDA 510(k) clearance for the LOOP™ LED Curing Light System (CLK01). Classified as Activator, Ultraviolet, For Polymerization (product code EBZ), Class II - Special Controls.

Submitted by Garrison Dental Solutions, LLC (Spring Lake, US). The FDA issued a Cleared decision on August 1, 2024 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6070 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Garrison Dental Solutions, LLC devices

Submission Details

510(k) Number K241238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBZ Activator, Ultraviolet, For Polymerization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6070
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBZ Activator, Ultraviolet, For Polymerization

All 212
Devices cleared under the same product code (EBZ) and FDA review panel - the closest regulatory comparables to K241238.
Demi Pro
K253461 · Meta Systems Co., Ltd. · Oct 2025
Bluemoon
K242386 · Genoss Co., Ltd. · May 2025
LED Curing Lights (DB686 HALO)
K243921 · Foshan Coxo Medical Instrument Co., Ltd. · Apr 2025
LED Curing Light (C01-X, C02-X)
K250009 · Premium Plus (Dongguan) Limited · Apr 2025
Curing Light, Model: MaxCure 9
K223414 · Guilin Refine Medical Instrument Co., Ltd. · Nov 2023
BASE290 LED Curing Light
K233518 · Handpiece Headquarters · Nov 2023