Fusion Curing Light

Q: What is the product code of K052593?

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) K052593 · Dentlight, Inc.

Substantially Equivalent

510(k) numberK052593

Submission

Device name: Fusion Curing Light
Applicant: Dentlight, Inc.
Richardson, TX, US
Received: September 21, 2005
Decision date: September 28, 2005
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

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
K201387	Ultrafast, Ultrafast Plus, Ultrafast LiteNVK · Traditional	02/26/2021SE
K180065	FUSION Plus Curing LightEBZ · Traditional	04/19/2019SE
K101140	Dentlight Oral Exam Light KitNXV · Traditional	07/15/2010SE

Questions and answers

When was Fusion Curing Light cleared by the FDA?

Fusion Curing Light (K052593) received a 510(k) decision of Substantially Equivalent on September 28, 2005, 7 days after the submission was received.

What is the product code of K052593?

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