Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LOOP™ LED Curing Light System (CLK01)

K-Number: K241238 · 2024-08-01

ApplicantGarrison Dental Solutions, LLC
Decision Date2024-08-01
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LOOP™ LED Curing Light System (CLK01) is a medical device manufactured by Garrison Dental Solutions, LLC. It received FDA 510(k) clearance on 2024-08-01 under approval number K241238. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOOP™ LED Curing Light System (CLK01)?

LOOP™ LED Curing Light System (CLK01) is a medical device that received FDA 510(k) clearance on 2024-08-01. It is manufactured by Garrison Dental Solutions, LLC. The 510(k) number is K241238.

When was LOOP™ LED Curing Light System (CLK01) approved by the FDA?

LOOP™ LED Curing Light System (CLK01) received FDA 510(k) clearance on 2024-08-01, under approval number K241238.

What company makes LOOP™ LED Curing Light System (CLK01)?

LOOP™ LED Curing Light System (CLK01) is manufactured by Garrison Dental Solutions, LLC.

What is the FDA product code for LOOP™ LED Curing Light System (CLK01)?

The FDA product code for LOOP™ LED Curing Light System (CLK01) is EBZ.

Related Clinical Trials

NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT07598305 PICN Versus Bioactive Composite for Cervical Restorations in Ballet Dancers COMPLETED NCT06655844 Sana Device for Post-Treatment Lyme Disease Syndrome Chronic Pain RECRUITING NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05260177 Study on the Effect of 40 Hz Non-Invasive Light Therapy System RECRUITING

Other Devices by Garrison Dental Solutions, LLC

K200775LOOP LED Curing Light System

Related Devices (Code: EBZ)

K153514Premium Plus C01/C02 LED Curing LightPremium Plus International Limited K160551VALO GrandUltradent Products, Inc. K153078LED Curing Light GT-2000Monitex Industrial Co., Ltd. K153018CELALUX 3Voco GmbH K161855LED Curing LightMonitex Industrial Co., Ltd. K172426Clear Blue Digi LED Curing LightPromident, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑