EBZ · Class II · 21 CFR 872.6070

FDA Product Code EBZ: Activator, Ultraviolet, For Polymerization

Leading manufacturers include Ultradent Products, Inc., Ivoclar Vivadent, Inc. and Dentsply Intl..

214
Total
214
Cleared
95d
Avg days
1977
Since
Declining activity - 5 submissions in the last 2 years vs 7 in the prior period
Review times increasing: avg 150d recently vs 94d historically

FDA 510(k) Cleared Activator, Ultraviolet, For Polymerization Devices (Product Code EBZ)

214 devices
1–24 of 214
Cleared Jun 18, 2026
Curing Light (M-Cure 6)
K253131
Guangzhou Rebornendo Medical Instrument Co., Ltd.
Dental · 266d
Cleared Oct 14, 2025
Demi Pro
K253461
Meta Systems Co., Ltd.
Dental · 7d
Cleared May 05, 2025
Bluemoon
K242386
Genoss Co., Ltd.
Dental · 266d
Cleared Apr 11, 2025
LED Curing Lights (DB686 HALO)
K243921
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 112d
Cleared Apr 10, 2025
LED Curing Light (C01-X, C02-X)
K250009
Premium Plus (Dongguan) Limited
Dental · 98d
Cleared Aug 01, 2024
LOOP™ LED Curing Light System (CLK01)
K241238
Garrison Dental Solutions, LLC
Dental · 90d
Cleared Nov 15, 2023
Curing Light, Model: MaxCure 9
K223414
Guilin Refine Medical Instrument Co., Ltd.
Dental · 370d
Cleared Nov 02, 2023
BASE290 LED Curing Light
K233518
Handpiece Headquarters
Dental · 1d
Cleared Aug 04, 2023
CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)
K223507
Good Doctors Co., Ltd.
Dental · 255d
Cleared Dec 22, 2022
Coltolux Comfort LED Curing Light
K223142
Dent4you AG
Dental · 79d
Cleared Dec 08, 2022
LED Curing Light
K220826
Foshan Coxo Medical Instrument Co., Ltd.
Dental · 261d
Cleared Nov 23, 2022
CuringPen Dental Curing Light
K221152
Changzhou Sifary Medical Technology Co., Ltd.
Dental · 217d
Cleared Sep 16, 2022
LEDEX
K221194
Dentmate Technology Co. , Ltd.
Dental · 144d
Cleared Feb 22, 2022
VALO X, VALO X Accessory Lenses
K220471
Ultradent Products, Inc.
Dental · 4d
Cleared Mar 01, 2021
VALO Grand Corded and Accessory Lenses
K210550
Ultradent Products, Inc.
Dental · 4d
Cleared Aug 14, 2020
LOOP LED Curing Light System
K200775
Garrison Dental Solutions, LLC
Dental · 142d
Cleared Aug 07, 2020
D-LUX+
K200809
DiaDent Group International
Dental · 133d
Cleared Feb 13, 2020
LED Curing Light
K192233
Foshan Cicada Dental Instrument Co, Ltd.
Dental · 178d
Cleared Jan 10, 2020
Cybird LED Curing Light
K191221
Dxm Co., Ltd.
Dental · 248d
Cleared Jan 09, 2020
LED Curing Light
K192009
Ezgo Group, Inc.
Dental · 164d
Cleared Nov 20, 2019
SmartLite Pro Modular LED Curing Light
K191865
Dentsply Sirona
Dental · 131d
Cleared Jul 03, 2019
Bluephase PowerCure
K190272
Ivoclar Vivadent, AG
Dental · 145d
Cleared Apr 29, 2019
VALO Grand Corded
K190627
Ultradent Products, Inc.
Dental · 48d
Cleared Apr 19, 2019
FUSION Plus Curing Light
K180065
Dentlight, Inc.
Dental · 465d

About Product Code EBZ - Regulatory Context

510(k) Submission Activity

214 total 510(k) submissions under product code EBZ since 1977, with 214 receiving FDA clearance (average review time: 95 days).

Submission volume has declined in recent years - 5 submissions in the last 24 months compared to 7 in the prior period.

FDA 510(k) Review Time - EBZ Product Code

Recent submissions under EBZ have taken an average of 150 days to reach a decision - up from 94 days historically. Manufacturers should account for longer review timelines in current project planning.

EBZ devices are reviewed by the Dental panel. Browse all Dental devices →