Manufacturer registered with FDA
IDIS Co. Ltd.
Bucheon-si, South Korea. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 12023–2023
- Markets registered in
- 1United States
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Devices listed with FDA
What IDIS 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-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Ni2 Implant SystemS-Plant Dental Implant System | 2024 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | S-Plant Dental Implant System | 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
IDIS Co. Ltd. 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: newton implant systems (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Apr 2024 | K221847 | Ni2 Implant System | newton implant systems | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| IDIS CO., LTD.FDA reg. 3026365523 | Bucheon-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10089789). 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.