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 8 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 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
Cleared Apr 01, 2019
Le'Pen
K181597
Kmihh, Ltd.
Dental · 287d

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 8 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 →