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FDA 510(k)

BONART ART-L5 LED CORDLESS CURING LIGHT

K-Number: K082971 · 2008-11-13

ApplicantBonart Co., Ltd.
Decision Date2008-11-13
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONART ART-L5 LED CORDLESS CURING LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Bonart Co., Ltd.. It received FDA 510(k) clearance on 2008-11-13 under 510(k) number K082971. 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 BONART ART-L5 LED CORDLESS CURING LIGHT?

BONART ART-L5 LED CORDLESS CURING LIGHT is a medical device that received FDA 510(k) clearance on 2008-11-13. The listed applicant is Bonart Co., Ltd.. The 510(k) number is K082971.

When did BONART ART-L5 LED CORDLESS CURING LIGHT receive FDA 510(k) clearance?

BONART ART-L5 LED CORDLESS CURING LIGHT received FDA 510(k) clearance on 2008-11-13, under 510(k) number K082971.

Who is the listed applicant for BONART ART-L5 LED CORDLESS CURING LIGHT?

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

What is the FDA product code for BONART ART-L5 LED CORDLESS CURING LIGHT?

The FDA product code for BONART ART-L5 LED CORDLESS CURING LIGHT is EBZ.

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Other records listing Bonart Co., Ltd. as applicant

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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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