Manufacturer registered with FDA
Dentlight, Inc.
Plano, TX, United States. Lists 4 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 11
- 510(k) clearances
- 32005–2019
- Markets registered in
- 33 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Dentlight, Inc. 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 | Dentlight, Inc. | 3 clearances | 2005–2019 | Below |
| Taiwan | TFDA | Manufacturer | DENTLIGHT INCDentLight Inc. | 2 | 2019–2024 | Pure Global AI |
| Israel | AMAR | Manufacturer | DentLight Inc | 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 Dentlight, Inc. 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 | FUSION Curing LightFUSION Plus-Grand Curing Light | 2005 |
| Ultraviolet DetectorEAQ · Class 2 | — | Maker | Dentlight Oral Exam Light KitDOEDOE SEFUSION-DOE | 2010 |
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Maker | iZoom | 2007 |
| Soft Tissue Detector Diagnostic LightNXV · Class 2 | — | Maker | Dentlight Oral Exam Light KitDOEDOE SEFUSION-DOE | 2010 |
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 Dentlight, Inc. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTLIGHT INC.FDA reg. 3005515469 | Plano, TX, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9077801). 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.