510(k) K223142
- Device
- Coltolux Comfort LED Curing Light
- Applicant
- Dent4you AG
- 510(k) number
- K223142
- Product code
- EBZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-12-22
- Date received
- 2022-10-04
- 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
- Dr. Tricia Cregger
- Address
- Bahnhofstrasse 2 Heerbrugg CH 9435 9435
FDA Registration Numbers
- 1410097
- 3006984716
- 9612352
- 3002807636
- 1420089
- 3006847937
- 9710363
- 3009307635
- 3012187973
- 3003933619
- 3007113232
- 3016075921
- 3005665377
- 3012771684
- 3008770655
- 3003169405
- 3003637274
- 3002807050
- 3003694926
- 3002957626
- 1937100
- 3004884150
- 1836088
- 2024949
- 3019381139
- 8010908
- 1718476
- 3038718579
- 8044015
- 9615399
- 3013641573
- 3005515469
- 2411797
- 1000493628
- 3010864832
- 3006654680
- 3032027578
- 3011300255
- 2031508
- 3027234828
- 2515379
- 3005581016
- 3043226252
- 3007007357
- 2416455
- 9680864
- 8044167
- 8043962
- 1032227
- 3004425647
- 9612300
- 9614977
- 3004082121
- 2126683
- 3007663058
- 2523990
- 8010638
- 3030126955
- 3014953747
- 3005972890
- 3006186796
- 3016543896
- 3011824442
- 2183301
- 2133714
- 3035693034
- 1718912
- 3007284437
- 3000219976
- 3023861999
- 3007662989
- 3006113314
- 3009496224
- 3022516928
- 1419489
- 3006621353
- 3009142030
- 9611385
- 3016875543
- 9681479
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07630392903417 | Coltolux Comfort | Dent4You AG | 2023-02-01 |
| 17630392901465 | Coltolux Comfort | Dent4You AG | 2023-02-01 |
| 17630392901458 | Coltolux Comfort | Dent4You AG | 2023-02-01 |
| 17630392901441 | Coltolux Comfort | Dent4You AG | 2023-02-01 |
| 17630392901434 | Coltolux Comfort | Dent4You AG | 2023-02-01 |
| 07630392901420 | Coltolux Comfort | Dent4You AG | 2023-02-01 |
| 07630392901413 | Coltolux Comfort | Dent4You AG | 2023-02-01 |
| 07630392901406 | Coltolux Comfort | Dent4You AG | 2023-02-01 |
Other 510(k) Records For Product Code EBZ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253461 | Demi Pro | Meta Systems Co., Ltd. | 2025-10-14 |
| K242386 | Bluemoon | Genoss Co., Ltd. | 2025-05-05 |
| K243921 | LED Curing Lights (DB686 HALO) | Foshan Coxo Medical Instrument Co., Ltd. | 2025-04-11 |
| K250009 | LED Curing Light (C01-X, C02-X) | Premium Plus (Dongguan) Limited | 2025-04-10 |
| K241238 | LOOP LED Curing Light System (CLK01) | Garrison Dental Solutions, LLC | 2024-08-01 |
| K223414 | Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., Ltd. | 2023-11-15 |
| K233518 | BASE290 LED Curing Light | Handpiece Headquarters | 2023-11-02 |
| K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE) | Good Doctors Co., Ltd. | 2023-08-04 |
| K220826 | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | 2022-12-08 |
| K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | 2022-11-23 |
| K221194 | LEDEX | Dentmate Technology Co. , Ltd. | 2022-09-16 |
| K220471 | VALO X, VALO X Accessory Lenses | Ultradent Products, Inc. | 2022-02-22 |
| K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | 2021-03-01 |
| K200775 | LOOP LED Curing Light System | Garrison Dental Solutions, LLC | 2020-08-14 |
| K200809 | D-LUX+ | DiaDent Group International | 2020-08-07 |