Manufacturer registered with FDA
IDS Korea
Seoul, South Korea. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1South Korea
Devices listed with FDA
What IDS Korea currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Porcelain Powder | 2020 |
| Preformed CrownELZ · Class 1 | — | Maker | DentsplyE-MAX CrownPorcelain Fused to Metal CrownTiconium | 2008 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Nobel Biocare | 2012 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Nobel Biocare | 2012 |
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
IDS Korea 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: U&C International Co., Ltd. (1), Prismatik Dentalcraft, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Oct 2019 | K191902 | Razor, Everest, U&C Liquid | U&C International Co., Ltd. | EIH Porcelain Powder |
| 15 Dec 2014 | K143330 | BruxZir Anterior | Prismatik Dentalcraft, Inc. | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| IDS KOREAFDA reg. 3007160911 | Seoul, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027020). 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.