FDA 510(k)

LED Curing Light (C01-X, C02-X)

K-Number: K250009 · 2025-04-10

ApplicantPremium Plus (Dongguan) Limited

Decision Date2025-04-10

Product CodeEBZ

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

LED Curing Light (C01-X, C02-X) is a medical device manufactured by Premium Plus (Dongguan) Limited. It received FDA 510(k) clearance on 2025-04-10 under approval number K250009. 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 Curing Light (C01-X, C02-X)?

LED Curing Light (C01-X, C02-X) is a medical device that received FDA 510(k) clearance on 2025-04-10. It is manufactured by Premium Plus (Dongguan) Limited. The 510(k) number is K250009.

When was LED Curing Light (C01-X, C02-X) approved by the FDA?

LED Curing Light (C01-X, C02-X) received FDA 510(k) clearance on 2025-04-10, under approval number K250009.

What company makes LED Curing Light (C01-X, C02-X)?

LED Curing Light (C01-X, C02-X) is manufactured by Premium Plus (Dongguan) Limited.

What is the FDA product code for LED Curing Light (C01-X, C02-X)?

The FDA product code for LED Curing Light (C01-X, C02-X) is EBZ.

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Other Devices by Premium Plus (Dongguan) Limited

K220662Disposable Barrier Sleeves K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)

Related Devices (Code: EBZ)

K153514Premium Plus C01/C02 LED Curing LightPremium Plus International Limited K160551VALO GrandUltradent Products, Inc. K153078LED Curing Light GT-2000Monitex Industrial Co., Ltd. K153018CELALUX 3Voco GmbH K161855LED Curing LightMonitex Industrial Co., Ltd. K172426Clear Blue Digi LED Curing LightPromident, 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.