FUSION Plus Curing Light

FDA 510(k) K180065 · Dentlight, Inc.

Substantially Equivalent

510(k) numberK180065

Submission

Device name
FUSION Plus Curing Light
Applicant
Dentlight, Inc.
Plano, TX, US
Received
January 9, 2018
Decision date
April 19, 2019
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

510(k)DeviceApplicantDecision
K253131Curing Light (M-Cure 6)EBZ · Traditional Guangzhou Rebornendo Medical Instrument Co., Ltd.06/18/2026SE
K253461Demi ProEBZ · Traditional Meta Systems Co., Ltd.10/14/2025SE
K242386BluemoonEBZ · Traditional Genoss Co., Ltd.05/05/2025SE
K243921LED Curing Lights (DB686 HALO)EBZ · Traditional Foshan Coxo Medical Instrument Co., Ltd.04/11/2025SE
K250009LED Curing Light (C01-X, C02-X)EBZ · Traditional Premium Plus (Dongguan) Limited04/10/2025SE
K241238LOOP™ LED Curing Light System (CLK01)EBZ · Traditional Garrison Dental Solutions, LLC08/01/2024SE
K223414Curing Light, Model: MaxCure 9EBZ · Traditional Guilin Refine Medical Instrument Co., Ltd.11/15/2023SE
K233518BASE290 LED Curing LightEBZ · Traditional Handpiece Headquarters11/02/2023SE
K223507CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)EBZ · Traditional Good Doctors Co., Ltd.08/04/2023SE
K223142Coltolux Comfort LED Curing LightEBZ · Traditional Dent4you AG12/22/2022SE

More from Dent4you AG

510(k)DeviceDecision
K201387Ultrafast, Ultrafast Plus, Ultrafast LiteNVK · Traditional 02/26/2021SE
K101140Dentlight Oral Exam Light KitNXV · Traditional 07/15/2010SE
K052593Fusion Curing LightEBZ · Traditional 09/28/2005SE

Questions and answers

When was FUSION Plus Curing Light cleared by the FDA?

FUSION Plus Curing Light (K180065) received a 510(k) decision of Substantially Equivalent on April 19, 2019, 465 days after the submission was received.

What is the product code of K180065?

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