Manufacturer registered with FDA
DENTALL Co., Ltd.
Bucheon-si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 32006–2017
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 2 markets
Where regulators' registries name DENTALL 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 | DENTALL Co., Ltd. | 3 clearances | 2006–2017 | Below |
| Taiwan | TFDA | Manufacturer | Dentall Co., Ltd. | 1 | 2024–2024 | 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 DENTALL 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 | B&Lite S | 2017 |
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 DENTALL Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 8 Aug 2017 | K170529 | Delight, Delight ortho, B&Lite S | EBZ Ultraviolet Activator for Polymerization |
| 3 Aug 2015 | K140432 | HI-LIGHT, HI-LIGHT PLUS | EBZ Ultraviolet Activator for Polymerization |
| 18 Sep 2006 | K061658 | SPIRIT, MODEL M, U; DOCPORTMACRO, MODEL M, U, L | EBZ Ultraviolet Activator for Polymerization |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTALL Co., Ltd.FDA reg. 3009307635 | Bucheon-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10037262). 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.