Manufacturer registered with FDA
8dent Inc.
Gimhae-si, South Korea. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3,312
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1South Korea
Registered in 2 markets
Where regulators' registries name 8dent Inc. as the manufacturer or the registration holder of a device.
RegisteredHome: South KoreaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | 8dent Inc. | 2 device types | — | Below |
| China | NMPA | Registration holder | 艾登株式会社 8dent Inc. | 3 | — | 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 8dent 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | ADD-ON Implant System - ADAAM4010ADD-ON Implant System - ADAAM4020ADD-ON Implant System - ADAAM4030ADD-ON Implant System - ADAAM4040ADD-ON Implant System - ADAAM4510ADD-ON Implant System - ADAAM4520ADD-ON Implant System - ADAAM4530ADD-ON Implant System - ADAAM4540ADD-ON Implant System - ADAAR4010ADD-ON Implant System - ADAAR4020 1,646 moreADD-ON Implant System - ADAAR4030ADD-ON Implant System - ADAAR4040ADD-ON Implant System - ADAAR4510ADD-ON Implant System - ADAAR4520ADD-ON Implant System - ADAAR4530ADD-ON Implant System - ADAAR4540ADD-ON Implant System - ADAAR5010ADD-ON Implant System - ADAAR5020ADD-ON Implant System - ADAAR5030ADD-ON Implant System - ADAAR5040ADD-ON Implant System - ADAAR6010ADD-ON Implant System - ADAAR6020ADD-ON Implant System - ADAAR6030ADD-ON Implant System - ADAAR6040ADD-ON Implant System - ADHAM4010ADD-ON Implant System - ADHAM4011ADD-ON Implant System - ADHAM4012ADD-ON Implant System - ADHAM403ADD-ON Implant System - ADHAM404ADD-ON Implant System - ADHAM405ADD-ON Implant System - ADHAM406ADD-ON Implant System - ADHAM407ADD-ON Implant System - ADHAM408ADD-ON Implant System - ADHAM409ADD-ON Implant System - ADHAM4510ADD-ON Implant System - ADHAM4511ADD-ON Implant System - ADHAM4512ADD-ON Implant System - ADHAM453ADD-ON Implant System - ADHAM454ADD-ON Implant System - ADHAM455ADD-ON Implant System - ADHAM456ADD-ON Implant System - ADHAM457ADD-ON Implant System - ADHAM458ADD-ON Implant System - ADHAM459ADD-ON Implant System - ADHAR4010ADD-ON Implant System - ADHAR4011ADD-ON Implant System - ADHAR4012ADD-ON Implant System - ADHAR403ADD-ON Implant System - ADHAR404ADD-ON Implant System - ADHAR405ADD-ON Implant System - ADHAR406ADD-ON Implant System - ADHAR407ADD-ON Implant System - ADHAR408ADD-ON Implant System - ADHAR409ADD-ON Implant System - ADHAR4510ADD-ON Implant System - ADHAR4511ADD-ON Implant System - ADHAR4512ADD-ON Implant System - ADHAR453ADD-ON Implant System - ADHAR454ADD-ON Implant System - ADHAR455ADD-ON Implant System - ADHAR456ADD-ON Implant System - ADHAR457ADD-ON Implant System - ADHAR458ADD-ON Implant System - ADHAR459ADD-ON Implant System - ADHAR5010ADD-ON Implant System - ADHAR5011ADD-ON Implant System - ADHAR5012ADD-ON Implant System - ADHAR503ADD-ON Implant System - ADHAR504ADD-ON Implant System - ADHAR505ADD-ON Implant System - ADHAR506ADD-ON Implant System - ADHAR507ADD-ON Implant System - ADHAR508ADD-ON Implant System - ADHAR509ADD-ON Implant System - ADHAR5510ADD-ON Implant System - ADHAR5511ADD-ON Implant System - ADHAR5512ADD-ON Implant System - ADHAR553ADD-ON Implant System - ADHAR554ADD-ON Implant System - ADHAR555ADD-ON Implant System - ADHAR556ADD-ON Implant System - ADHAR557ADD-ON Implant System - ADHAR558ADD-ON Implant System - ADHAR559ADD-ON Implant System - ADHAR6010ADD-ON Implant System - ADHAR6011ADD-ON Implant System - ADHAR6012ADD-ON Implant System - ADHAR603ADD-ON Implant System - ADHAR604ADD-ON Implant System - ADHAR605ADD-ON Implant System - ADHAR606ADD-ON Implant System - ADHAR607ADD-ON Implant System - ADHAR608ADD-ON Implant System - ADHAR609ADD-ON Implant System - ADHAR6510ADD-ON Implant System - ADHAR6511ADD-ON Implant System - ADHAR6512ADD-ON Implant System - ADHAR653ADD-ON Implant System - ADHAR654ADD-ON Implant System - ADHAR655ADD-ON Implant System - ADHAR656ADD-ON Implant System - ADHAR657ADD-ON Implant System - ADHAR658ADD-ON Implant System - ADHAR659ADD-ON Implant System - ADHAR7010ADD-ON Implant System - ADHAR7011ADD-ON Implant System - ADHAR7012ADD-ON Implant System - ADHAR703ADD-ON Implant System - ADHAR704ADD-ON Implant System - ADHAR705ADD-ON Implant System - ADHAR706ADD-ON Implant System - ADHAR707ADD-ON Implant System - ADHAR708ADD-ON Implant System - ADHAR709ADD-ON Implant System - ADHAR8010ADD-ON Implant System - ADHAR8011ADD-ON Implant System - ADHAR8012ADD-ON Implant System - ADHAR803ADD-ON Implant System - ADHAR804ADD-ON Implant System - ADHAR805ADD-ON Implant System - ADHAR806ADD-ON Implant System - ADHAR807ADD-ON Implant System - ADHAR808ADD-ON Implant System - ADHAR809ADD-ON Implant System - ADLCAM3510ADD-ON Implant System - ADLCAM3520ADD-ON Implant System - ADLCAM3530ADD-ON Implant System - ADLCAM3540ADD-ON Implant System - ADLCAM3550ADD-ON Implant System - ADLCAM3560ADD-ON Implant System - ADLCAR4010ADD-ON Implant System - ADLCAR4020ADD-ON Implant System - ADLCAR4030ADD-ON Implant System - ADLCAR4040ADD-ON Implant System - ADLCAR4050ADD-ON Implant System - ADLCAR4060ADD-ON Implant System - ADOAM404010ADD-ON Implant System - ADOAM404020ADD-ON Implant System - ADOAM404030ADD-ON Implant System - ADOAM404040ADD-ON Implant System - ADOAM404050ADD-ON Implant System - ADOAM404060ADD-ON Implant System - ADOAM404070ADD-ON Implant System - ADOAM404080ADD-ON Implant System - ADOAM405510ADD-ON Implant System - ADOAM405520ADD-ON Implant System - ADOAM405530ADD-ON Implant System - ADOAM405540ADD-ON Implant System - ADOAM405550ADD-ON Implant System - ADOAM405560 | 2024 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | ADD-ON Implant System - ADAAM4010ADD-ON Implant System - ADAAM4020ADD-ON Implant System - ADAAM4030ADD-ON Implant System - ADAAM4040ADD-ON Implant System - ADAAM4510ADD-ON Implant System - ADAAM4520ADD-ON Implant System - ADAAM4530ADD-ON Implant System - ADAAM4540ADD-ON Implant System - ADAAR4010ADD-ON Implant System - ADAAR4020 1,646 moreADD-ON Implant System - ADAAR4030ADD-ON Implant System - ADAAR4040ADD-ON Implant System - ADAAR4510ADD-ON Implant System - ADAAR4520ADD-ON Implant System - ADAAR4530ADD-ON Implant System - ADAAR4540ADD-ON Implant System - ADAAR5010ADD-ON Implant System - ADAAR5020ADD-ON Implant System - ADAAR5030ADD-ON Implant System - ADAAR5040ADD-ON Implant System - ADAAR6010ADD-ON Implant System - ADAAR6020ADD-ON Implant System - ADAAR6030ADD-ON Implant System - ADAAR6040ADD-ON Implant System - ADHAM4010ADD-ON Implant System - ADHAM4011ADD-ON Implant System - ADHAM4012ADD-ON Implant System - ADHAM403ADD-ON Implant System - ADHAM404ADD-ON Implant System - ADHAM405ADD-ON Implant System - ADHAM406ADD-ON Implant System - ADHAM407ADD-ON Implant System - ADHAM408ADD-ON Implant System - ADHAM409ADD-ON Implant System - ADHAM4510ADD-ON Implant System - ADHAM4511ADD-ON Implant System - ADHAM4512ADD-ON Implant System - ADHAM453ADD-ON Implant System - ADHAM454ADD-ON Implant System - ADHAM455ADD-ON Implant System - ADHAM456ADD-ON Implant System - ADHAM457ADD-ON Implant System - ADHAM458ADD-ON Implant System - ADHAM459ADD-ON Implant System - ADHAR4010ADD-ON Implant System - ADHAR4011ADD-ON Implant System - ADHAR4012ADD-ON Implant System - ADHAR403ADD-ON Implant System - ADHAR404ADD-ON Implant System - ADHAR405ADD-ON Implant System - ADHAR406ADD-ON Implant System - ADHAR407ADD-ON Implant System - ADHAR408ADD-ON Implant System - ADHAR409ADD-ON Implant System - ADHAR4510ADD-ON Implant System - ADHAR4511ADD-ON Implant System - ADHAR4512ADD-ON Implant System - ADHAR453ADD-ON Implant System - ADHAR454ADD-ON Implant System - ADHAR455ADD-ON Implant System - ADHAR456ADD-ON Implant System - ADHAR457ADD-ON Implant System - ADHAR458ADD-ON Implant System - ADHAR459ADD-ON Implant System - ADHAR5010ADD-ON Implant System - ADHAR5011ADD-ON Implant System - ADHAR5012ADD-ON Implant System - ADHAR503ADD-ON Implant System - ADHAR504ADD-ON Implant System - ADHAR505ADD-ON Implant System - ADHAR506ADD-ON Implant System - ADHAR507ADD-ON Implant System - ADHAR508ADD-ON Implant System - ADHAR509ADD-ON Implant System - ADHAR5510ADD-ON Implant System - ADHAR5511ADD-ON Implant System - ADHAR5512ADD-ON Implant System - ADHAR553ADD-ON Implant System - ADHAR554ADD-ON Implant System - ADHAR555ADD-ON Implant System - ADHAR556ADD-ON Implant System - ADHAR557ADD-ON Implant System - ADHAR558ADD-ON Implant System - ADHAR559ADD-ON Implant System - ADHAR6010ADD-ON Implant System - ADHAR6011ADD-ON Implant System - ADHAR6012ADD-ON Implant System - ADHAR603ADD-ON Implant System - ADHAR604ADD-ON Implant System - ADHAR605ADD-ON Implant System - ADHAR606ADD-ON Implant System - ADHAR607ADD-ON Implant System - ADHAR608ADD-ON Implant System - ADHAR609ADD-ON Implant System - ADHAR6510ADD-ON Implant System - ADHAR6511ADD-ON Implant System - ADHAR6512ADD-ON Implant System - ADHAR653ADD-ON Implant System - ADHAR654ADD-ON Implant System - ADHAR655ADD-ON Implant System - ADHAR656ADD-ON Implant System - ADHAR657ADD-ON Implant System - ADHAR658ADD-ON Implant System - ADHAR659ADD-ON Implant System - ADHAR7010ADD-ON Implant System - ADHAR7011ADD-ON Implant System - ADHAR7012ADD-ON Implant System - ADHAR703ADD-ON Implant System - ADHAR704ADD-ON Implant System - ADHAR705ADD-ON Implant System - ADHAR706ADD-ON Implant System - ADHAR707ADD-ON Implant System - ADHAR708ADD-ON Implant System - ADHAR709ADD-ON Implant System - ADHAR8010ADD-ON Implant System - ADHAR8011ADD-ON Implant System - ADHAR8012ADD-ON Implant System - ADHAR803ADD-ON Implant System - ADHAR804ADD-ON Implant System - ADHAR805ADD-ON Implant System - ADHAR806ADD-ON Implant System - ADHAR807ADD-ON Implant System - ADHAR808ADD-ON Implant System - ADHAR809ADD-ON Implant System - ADLCAM3510ADD-ON Implant System - ADLCAM3520ADD-ON Implant System - ADLCAM3530ADD-ON Implant System - ADLCAM3540ADD-ON Implant System - ADLCAM3550ADD-ON Implant System - ADLCAM3560ADD-ON Implant System - ADLCAR4010ADD-ON Implant System - ADLCAR4020ADD-ON Implant System - ADLCAR4030ADD-ON Implant System - ADLCAR4040ADD-ON Implant System - ADLCAR4050ADD-ON Implant System - ADLCAR4060ADD-ON Implant System - ADOAM404010ADD-ON Implant System - ADOAM404020ADD-ON Implant System - ADOAM404030ADD-ON Implant System - ADOAM404040ADD-ON Implant System - ADOAM404050ADD-ON Implant System - ADOAM404060ADD-ON Implant System - ADOAM404070ADD-ON Implant System - ADOAM404080ADD-ON Implant System - ADOAM405510ADD-ON Implant System - ADOAM405520ADD-ON Implant System - ADOAM405530ADD-ON Implant System - ADOAM405540ADD-ON Implant System - ADOAM405550ADD-ON Implant System - ADOAM405560 | 2024 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
8dent Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Hoowon Edi Co., Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 May 2024 | K231426 | 8plant Implant System | Hoowon Edi Co., Ltd. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| 8dent Inc.FDA reg. 3033519161 | Gimhae-si Gyeongnam, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091412). 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.