Manufacturer registered with FDA
Inno Dental Co Ltd
Seoul, South Korea. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 510 registrations outside the US
- Establishments
- 1South Korea
Registered in 5 markets
Where regulators' registries name Inno Dental 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 | Inno Dental Co Ltd | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | INNO DENTAL CO., LTD.INNODENTAL CO LTD. | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Inno Dental Co. Ltd.INNO Dental CO., LTD | 3 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | INNO DENTAL CO., LTD. | 3 | 2014–2020 | Pure Global AI |
| Australia | TGA | Manufacturer | Inno Dental 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 Inno Dental 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 |
|---|---|---|---|---|
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Q.P Fiber Post Plus RefillQ.P. Fiber Post Plus | 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 |
|---|---|---|
| INNO DENTAL CO., LTD.FDA reg. 3018159969 | Seoul, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10081069). 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.