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FDA 510(k)

FUSION CURING LIGHT

K-Number: K052593 · 2005-09-28

ApplicantDentlight, Inc.
Decision Date2005-09-28
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FUSION CURING LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Dentlight, Inc.. It received FDA 510(k) clearance on 2005-09-28 under 510(k) number K052593. 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 FUSION CURING LIGHT?

FUSION CURING LIGHT is a medical device that received FDA 510(k) clearance on 2005-09-28. The listed applicant is Dentlight, Inc.. The 510(k) number is K052593.

When did FUSION CURING LIGHT receive FDA 510(k) clearance?

FUSION CURING LIGHT received FDA 510(k) clearance on 2005-09-28, under 510(k) number K052593.

Who is the listed applicant for FUSION CURING LIGHT?

The FDA 510(k) record lists Dentlight, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUSION CURING LIGHT?

The FDA product code for FUSION CURING LIGHT is EBZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Dentlight, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201387Ultrafast, Ultrafast Plus, Ultrafast LiteK180065FUSION Plus Curing LightK101140DENTLIGHT ORAL EXAM LIGHT KIT

Related Devices (Code: EBZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, 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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