FDA.report

510(k) K241238

Device
LOOP? LED Curing Light System (CLK01)
Applicant
Garrison Dental Solutions, LLC
510(k) number
K241238
Product code
EBZ
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-01
Date received
2024-05-03
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
No

Related Records

Applicant Contact

Contact
Rhonda Allen
Address
150 Dewitt Ln. Spring Lake MI US 49456 49456

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
K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) Limited2025-04-10
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