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FDA 510(k)

LED TURBO

K-Number: K040618 · 2004-03-25

ApplicantApoza Enterprise Co., Ltd.
Decision Date2004-03-25
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LED TURBO is the device name listed in this FDA 510(k) record. The listed applicant is Apoza Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2004-03-25 under 510(k) number K040618. 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 LED TURBO?

LED TURBO is a medical device that received FDA 510(k) clearance on 2004-03-25. The listed applicant is Apoza Enterprise Co., Ltd.. The 510(k) number is K040618.

When did LED TURBO receive FDA 510(k) clearance?

LED TURBO received FDA 510(k) clearance on 2004-03-25, under 510(k) number K040618.

Who is the listed applicant for LED TURBO?

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

What is the FDA product code for LED TURBO?

The FDA product code for LED TURBO 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 Apoza Enterprise 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.

K070373APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5WK041303LED TURBO-PENK033198APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2K033201LA500 BLUE LIGHT

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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