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FDA 510(k)

LOOP LED Curing Light System

K-Number: K200775 · 2020-08-14

ApplicantGarrison Dental Solutions, LLC
Decision Date2020-08-14
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LOOP LED Curing Light System is a medical device manufactured by Garrison Dental Solutions, LLC. It received FDA 510(k) clearance on 2020-08-14 under approval number K200775. 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?

LOOP LED Curing Light System is a medical device that received FDA 510(k) clearance on 2020-08-14. It is manufactured by Garrison Dental Solutions, LLC. The 510(k) number is K200775.

When was LOOP LED Curing Light System approved by the FDA?

LOOP LED Curing Light System received FDA 510(k) clearance on 2020-08-14, under approval number K200775.

What company makes LOOP LED Curing Light System?

LOOP LED Curing Light System is manufactured by Garrison Dental Solutions, LLC.

What is the FDA product code for LOOP LED Curing Light System?

The FDA product code for LOOP LED Curing Light System is EBZ.

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Other Devices by Garrison Dental Solutions, LLC

K241238LOOP™ LED Curing Light System (CLK01)

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.

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