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FDA 510(k)

Clear Blue Digi LED Curing Light

K-Number: K172426 · 2017-08-16

ApplicantPromident, LLC
Decision Date2017-08-16
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Clear Blue Digi LED Curing Light is the device name listed in this FDA 510(k) record. The listed applicant is Promident, LLC. It received FDA 510(k) clearance on 2017-08-16 under 510(k) number K172426. 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 Clear Blue Digi LED Curing Light?

Clear Blue Digi LED Curing Light is a medical device that received FDA 510(k) clearance on 2017-08-16. The listed applicant is Promident, LLC. The 510(k) number is K172426.

When did Clear Blue Digi LED Curing Light receive FDA 510(k) clearance?

Clear Blue Digi LED Curing Light received FDA 510(k) clearance on 2017-08-16, under 510(k) number K172426.

Who is the listed applicant for Clear Blue Digi LED Curing Light?

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

What is the FDA product code for Clear Blue Digi LED Curing Light?

The FDA product code for Clear Blue Digi LED Curing Light is EBZ.

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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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