Manufacturer registered with FDA
Medit Corp.
Seoul, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 27
- 510(k) clearances
- 0as applicant
- Markets registered in
- 12114 registrations outside the US
- Establishments
- 1South Korea
Registered in 12 markets
Where regulators' registries name Medit Corp. 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 | Medit Corp. | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | MEDIT CORP. | 37 | 2019–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Medit Corp. | 21 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Medit Corp.Medit Corp | 11 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Medit CorpMedit Corp. | 10 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Medit Corp. | 9 | 2022–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MEDIT CORP. | 6 | 2021–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Medit Corp.MEDIT CORPORATION | 6 | 2018–2024 | Pure Global AI |
| Australia | TGA | Manufacturer | Medit Corp | 5 | 2022–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | MEDIT Corp. | 4 | — | Pure Global AI |
| China | NMPA | Registration holder | 美迪特MEDIT Corp.美迪特Medit Corp. | 3 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MEDIT CORP. | 2 | 2025–2026 | 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 Medit Corp. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | i500i600i700i700 wirelessi900i900 classici900 MobilityiEKaVo X 500KaVo X 700 15 moreMD-ID0300MD-ID0400MD-ID0420MD-RT0100MD-RT0200MD-RT0300MD-RT0400Medit ClinicCADMedit DesignMedit SplintsMO1-RTLMO1-RTMMO1-RTPMO1-RTSMO1-ST1 | 2017 |
| Orthodontic SoftwarePNN · Class 2 | Dental design & orthodontic software | Maker | Medit Orthodontic SuiteProgressive Orthodontics App. | 2025 |
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 |
|---|---|---|
| MEDIT CORP.FDA reg. 3021233709 | Seoul, South Korea | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054469). 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.