Manufacturer registered with FDA
Dentozone Corporation
Guro-gu, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 36 registrations outside the US
- Establishments
- 1South Korea
Registered in 3 markets
Where regulators' registries name Dentozone Corporation 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 | Dentozone Corporation | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | DENTOZONE CORPORATION | 5 | 2011–2013 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DENTOZONE | 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 Dentozone Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | eBite3S Blue Light | 2021 |
| Dental Retractor AccessoriesEIF · Class 1 | Dental hand instruments | Maker | Accessories for Suction Connector99 Suction Block | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTOZONE CORPORATIONFDA reg. 3006551266 | Guro-gu Seoul, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053187). 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.