Data / Medical devices / Taiwan / Dentmate Technology Co., Ltd.
Dentmate Technology Co., Ltd.: FDA-registered device maker in New Taipei, Taiwan, 4 510(k) clearances
Dentmate Technology Co., Ltd. is registered with the FDA (registration 3007662989) in New Taipei, Taiwan. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 16, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007662989
- Address
- 8F, No.8-11, Sec. 1, Zhongxing Road, Wugu District, New Taipei, Taiwan, 24872
- Owner or operator
- DENTMATE TECHNOLOGY CO., LTD. (10027927)
- Roles
- Manufacturer
- First device listed
- December 16, 2008
- Registered through
- 2026
- Brand names listed
- LEDEX, LEDEX WL-070 Dental Curing Light, LEDEX WL-070+ ; LEDEX WL-070+ ORTHO, LEDEX WL-090 Dental Curing Light, LEDEX WL-090+ Dental Curing Light, LUMINDEX 5 LED Headlight
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Manufacturer | accessdata.fda.gov |
| Headlamp, Operating, Battery-Operated | HPP | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2022 | K221194 | LEDEX | EBZ | Substantially Equivalent | Dentmate Technology Co. , Ltd. | accessdata.fda.gov |
| January 19, 2017 | K163605 | LEDEX WL070+ | EBZ | Substantially Equivalent | Dentmate Technology Co. , Ltd. | accessdata.fda.gov |
| October 3, 2013 | K131042 | LEDEX | EBZ | Substantially Equivalent | Dentmate Technology Co. , Ltd. | accessdata.fda.gov |
| December 3, 2008 | K082408 | LEDEX, MODEL: WL-070 | EBZ | Substantially Equivalent | Dentmate Technology Co. , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Activator, Ultraviolet, For Polymerization
- All makers of Headlamp, Operating, Battery-Operated
Updated September 16, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.