Premium Plus C01/C02 LED Curing Light

Q: What is the product code of K153514?

The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.

FDA 510(k) K153514 · Premium Plus International Limited

Substantially Equivalent

510(k) numberK153514

Submission

Device name: Premium Plus C01/C02 LED Curing Light
Applicant: Premium Plus International Limited
Hong Kong, CN
Received: December 7, 2015
Decision date: August 22, 2016
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: EBZ – Activator, Ultraviolet, For Polymerization
Device class: Class II (moderate risk)
Regulation: 21 CFR 872.6070
Specialty: Dental

Other 510(k)s with product code EBZ

510(k)	Device	Applicant	Decision
K253131	Curing Light (M-Cure 6)EBZ · Traditional	Guangzhou Rebornendo Medical Instrument Co., Ltd.	06/18/2026SE
K253461	Demi ProEBZ · Traditional	Meta Systems Co., Ltd.	10/14/2025SE
K242386	BluemoonEBZ · Traditional	Genoss Co., Ltd.	05/05/2025SE
K243921	LED Curing Lights (DB686 HALO)EBZ · Traditional	Foshan Coxo Medical Instrument Co., Ltd.	04/11/2025SE
K250009	LED Curing Light (C01-X, C02-X)EBZ · Traditional	Premium Plus (Dongguan) Limited	04/10/2025SE
K241238	LOOP LED Curing Light System (CLK01)EBZ · Traditional	Garrison Dental Solutions, LLC	08/01/2024SE
K223414	Curing Light, Model: MaxCure 9EBZ · Traditional	Guilin Refine Medical Instrument Co., Ltd.	11/15/2023SE
K233518	BASE290 LED Curing LightEBZ · Traditional	Handpiece Headquarters	11/02/2023SE
K223507	CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE)EBZ · Traditional	Good Doctors Co., Ltd.	08/04/2023SE
K223142	Coltolux Comfort LED Curing LightEBZ · Traditional	Dent4you AG	12/22/2022SE

More from Dent4you AG

510(k)	Device	Decision
K170261	Premium Plus Prophy Air MotorEFB · Abbreviated	10/19/2017SE
K163447	Premium Plus Disposable Barrier SleevePEM · Traditional	06/20/2017SE
K100854	Premium Plus Disposable Prophy Angle Model 3399EGS · Traditional	12/09/2010SE

Questions and answers

When was Premium Plus C01/C02 LED Curing Light cleared by the FDA?

Premium Plus C01/C02 LED Curing Light (K153514) received a 510(k) decision of Substantially Equivalent on August 22, 2016, 259 days after the submission was received.

What is the product code of K153514?

The FDA product code is EBZ – Activator, Ultraviolet, For Polymerization, a Class II (moderate risk) device regulated under 21 CFR 872.6070.