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FDA 510(k)

LEDEX, MODEL: WL-070

K-Number: K082408 · 2008-12-03

ApplicantDentmate Technology Co. , Ltd.
Decision Date2008-12-03
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LEDEX, MODEL: WL-070 is the device name listed in this FDA 510(k) record. The listed applicant is Dentmate Technology Co. , Ltd.. It received FDA 510(k) clearance on 2008-12-03 under 510(k) number K082408. 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 LEDEX, MODEL: WL-070?

LEDEX, MODEL: WL-070 is a medical device that received FDA 510(k) clearance on 2008-12-03. The listed applicant is Dentmate Technology Co. , Ltd.. The 510(k) number is K082408.

When did LEDEX, MODEL: WL-070 receive FDA 510(k) clearance?

LEDEX, MODEL: WL-070 received FDA 510(k) clearance on 2008-12-03, under 510(k) number K082408.

Who is the listed applicant for LEDEX, MODEL: WL-070?

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

What is the FDA product code for LEDEX, MODEL: WL-070?

The FDA product code for LEDEX, MODEL: WL-070 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 Dentmate Technology 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.

K221194LEDEXK163605LEDEX WL070+K131042LEDEX

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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