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FDA 510(k)

LED TURBO-PEN

K-Number: K041303 · 2004-06-18

ApplicantApoza Enterprise Co., Ltd.
Decision Date2004-06-18
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LED TURBO-PEN 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 2004-06-18 under 510(k) number K041303. 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-PEN?

LED TURBO-PEN is a medical device that received FDA 510(k) clearance on 2004-06-18. The listed applicant is Apoza Enterprise Co., Ltd.. The 510(k) number is K041303.

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

LED TURBO-PEN received FDA 510(k) clearance on 2004-06-18, under 510(k) number K041303.

Who is the listed applicant for LED TURBO-PEN?

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-PEN?

The FDA product code for LED TURBO-PEN 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 5WK033198APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2K040618LED TURBOK033201LA500 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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