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FDA 510(k)

BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855

K-Number: K060646 · 2006-04-21

ApplicantMonitex Industrial Co., Ltd.
Decision Date2006-04-21
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 is the device name listed in this FDA 510(k) record. The listed applicant is Monitex Industrial Co., Ltd.. It received FDA 510(k) clearance on 2006-04-21 under 510(k) number K060646. 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 BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855?

BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 is a medical device that received FDA 510(k) clearance on 2006-04-21. The listed applicant is Monitex Industrial Co., Ltd.. The 510(k) number is K060646.

When did BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 receive FDA 510(k) clearance?

BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 received FDA 510(k) clearance on 2006-04-21, under 510(k) number K060646.

Who is the listed applicant for BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855?

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

What is the FDA product code for BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855?

The FDA product code for BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855 is EBZ.

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Other records listing Monitex Industrial 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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