Manufacturer registered with FDA
DOF Inc
Seoul, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 58 registrations outside the US
- Establishments
- 1South Korea
Registered in 5 markets
Where regulators' registries name DOF 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 | DOF Inc | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | DOF Inc. | 4 | 2019–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DOF INC | 2 | 2025–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | DOF Inc | 1 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DOF INC. | 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 DOF 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | PIM KITPIM Scanbody | 2025 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | FREEDOM AirFREEDOM i | 2013 |
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 |
|---|---|---|
| DOF INCFDA reg. 3010158379 | Seoul, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10043268). 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.