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FDA 510(k)

SKYLIGHT LED CURING LIGHT

K-Number: K051571 · 2005-07-19

ApplicantDmetec.Co., Ltd.
Decision Date2005-07-19
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SKYLIGHT LED CURING LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Dmetec.Co., Ltd.. It received FDA 510(k) clearance on 2005-07-19 under 510(k) number K051571. 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 SKYLIGHT LED CURING LIGHT?

SKYLIGHT LED CURING LIGHT is a medical device that received FDA 510(k) clearance on 2005-07-19. The listed applicant is Dmetec.Co., Ltd.. The 510(k) number is K051571.

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

SKYLIGHT LED CURING LIGHT received FDA 510(k) clearance on 2005-07-19, under 510(k) number K051571.

Who is the listed applicant for SKYLIGHT LED CURING LIGHT?

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

What is the FDA product code for SKYLIGHT LED CURING LIGHT?

The FDA product code for SKYLIGHT LED CURING LIGHT is EBZ.

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Other records listing Dmetec.Co., Ltd. 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.

K170104COMPACT S, COMPACT S (LED)K121620ULTRASONIC SURGERYK113152ULTRASONIC SURGERY MACHINEK060171CLEANSE S+ ULTRASONIC SCALER

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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