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FDA 510(k)

Premium Plus C01/C02 LED Curing Light

K-Number: K153514 · 2016-08-22

ApplicantPremium Plus International Limited
Decision Date2016-08-22
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Premium Plus C01/C02 LED Curing Light is the device name listed in this FDA 510(k) record. The listed applicant is Premium Plus International Limited. It received FDA 510(k) clearance on 2016-08-22 under 510(k) number K153514. 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 Premium Plus C01/C02 LED Curing Light?

Premium Plus C01/C02 LED Curing Light is a medical device that received FDA 510(k) clearance on 2016-08-22. The listed applicant is Premium Plus International Limited. The 510(k) number is K153514.

When did Premium Plus C01/C02 LED Curing Light receive FDA 510(k) clearance?

Premium Plus C01/C02 LED Curing Light received FDA 510(k) clearance on 2016-08-22, under 510(k) number K153514.

Who is the listed applicant for Premium Plus C01/C02 LED Curing Light?

The FDA 510(k) record lists Premium Plus International Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Premium Plus C01/C02 LED Curing Light?

The FDA product code for Premium Plus C01/C02 LED Curing Light is EBZ.

Other records listing Premium Plus International Limited 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.

K170261Premium Plus Prophy Air MotorK163447Premium Plus Disposable Barrier Sleeve

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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