FDA.report

510(k) K250009

Device
LED Curing Light (C01-X, C02-X)
Applicant
Premium Plus (Dongguan) Limited
510(k) number
K250009
Product code
EBZ
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-10
Date received
2025-01-02
Regulation
872.6070
Classification name
Activator, Ultraviolet, For Polymerization
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Jessica Mao
Address
Flat 101, #122, Tianqiao Rd., Changping Dongguan CN 523581 523581

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code EBZ

510(k)DeviceApplicantDecision date
K253461Demi ProMeta Systems Co., Ltd.2025-10-14
K242386BluemoonGenoss Co., Ltd.2025-05-05
K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.2025-04-11
K241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC2024-08-01
K223414Curing Light, Model: MaxCure 9Guilin Refine Medical Instrument Co., Ltd.2023-11-15
K233518BASE290 LED Curing LightHandpiece Headquarters2023-11-02
K223507CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)Good Doctors Co., Ltd.2023-08-04
K223142Coltolux Comfort LED Curing LightDent4you AG2022-12-22
K220826LED Curing LightFoshan Coxo Medical Instrument Co., Ltd.2022-12-08
K221152CuringPen Dental Curing LightChangzhou Sifary Medical Technology Co., Ltd.2022-11-23
K221194LEDEXDentmate Technology Co. , Ltd.2022-09-16
K220471VALO X, VALO X Accessory LensesUltradent Products, Inc.2022-02-22
K210550VALO Grand Corded and Accessory LensesUltradent Products, Inc.2021-03-01
K200775LOOP LED Curing Light SystemGarrison Dental Solutions, LLC2020-08-14
K200809D-LUX+DiaDent Group International2020-08-07