Manufacturer registered with FDA
Dentmate Technology Co. , Ltd.
New Taipei City, Taiwan. Lists 1 dental device type with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 5
- 510(k) clearances
- 42008–2022
- Markets registered in
- 826 registrations outside the US
- Establishments
- 1Taiwan
510(k) clearances per year, 2000–2026
Registered in 8 markets
Where regulators' registries name Dentmate Technology Co. , Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Dentmate Technology Co. , Ltd. | 4 clearances | 2008–2022 | Below |
| South Korea | MFDS | Manufacturer | Dentmate Technology Co., Ltd.DENTMATE TECHNOLOGY CO.,LTD · DENTMATE TECHNOLOGY CO.,LTD. · +2 | 11 | 2013–2018 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DENTMATE TECHNOLOGY | 9 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Dentmate Technology CO LTD.Dentmate technology CO.,Ltd. | 2 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENTMATE TECHNOLOGY CO., LTD | 1 | 2016–2016 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DENTMATE TECHNOLOGY CO. LTD. | 1 | 2019–2019 | Pure Global AI |
| Tanzania | TMDA | Manufacturer | Dentmate Technology Co Ltd | 1 | 2025–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Dentmate Technology Co Ltd | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Dentmate Technology Co. , Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | LEDEXLEDEX WL-070 Dental Curing LightLEDEX WL-070+ ; LEDEX WL-070+ ORTHOLEDEX WL-090 Dental Curing LightLEDEX WL-090+ Dental Curing Light | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Dentmate Technology Co. , Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Sep 2022 | K221194 | LEDEX | EBZ Ultraviolet Activator for Polymerization |
| 19 Jan 2017 | K163605 | LEDEX WL070+ | EBZ Ultraviolet Activator for Polymerization |
| 3 Oct 2013 | K131042 | LEDEX | EBZ Ultraviolet Activator for Polymerization |
| 3 Dec 2008 | K082408 | LEDEX, MODEL: WL-070 | EBZ Ultraviolet Activator for Polymerization |
Some of these clearances are listed with FDA today by another company: Allure Ortho (1), Orthometric Ind. e Com. de Prod. Med. Odont. (1), Ortho Solutions LC (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTMATE TECHNOLOGY CO., LTD.FDA reg. 3007662989 | New Taipei, Taiwan | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027927). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.