Hi-Light, Hi-Light Plus

Q: What is the product code of K140432?

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) K140432 · Dentall Corporation

Substantially Equivalent

510(k) numberK140432

Submission

Device name: Hi-Light, Hi-Light Plus
Applicant: Dentall Corporation
Fullerton, CA, US
Received: February 20, 2014
Decision date: August 3, 2015
Decision: Substantially Equivalent (SESE)
Type: Traditional 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

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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
K170529	Delight, Delight ortho, B&Lite SEBZ · Traditional	08/08/2017SE
K061658	Spirit, Model M, U; Docportmacro, Model M, U, LEBZ · Traditional	09/18/2006SE

Questions and answers

When was Hi-Light, Hi-Light Plus cleared by the FDA?

Hi-Light, Hi-Light Plus (K140432) received a 510(k) decision of Substantially Equivalent on August 3, 2015, 529 days after the submission was received.

What is the product code of K140432?

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