Manufacturer registered with FDA
DENTALMAX Co., Ltd
Cheonan-si, South Korea. Lists 1 dental device type with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 4
- 510(k) clearances
- 32018–2024
- Markets registered in
- 1060 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 10 markets
Where regulators' registries name DENTALMAX 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 | DENTALMAX Co., Ltd | 3 clearances | 2018–2024 | Below |
| Argentina | ANMAT | Registration holder | DENTALMAX S.A. | 42 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | DENTALMAX CO., LTD. | 8 | 2017–2017 | Pure Global AI |
| Australia | TGA | Manufacturer | DENTALMAX Co Ltd | 2 | 2021–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DENTALMAX CO.,LTD | 2 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DENTALMAX Co., Ltd. | 2 | 2019–2019 | Pure Global AI |
| China | NMPA | Registration holder | 登泰美有限公司DentalMax Co., Ltd. | 1 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DENTALMAX Co., LTD | 1 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | DENTALMAX Co Ltd | 1 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | DENTALMAX Co., Ltd | 1 | 2025–2025 | 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 DENTALMAX 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 |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | LUXEN 5GLUXEN CL Dental LiquidLUXEN SmileLUXEN Zr | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names DENTALMAX Co., Ltd as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Sep 2024 | K241151 | LUXEN 5G | EIH Porcelain Powder |
| 6 Dec 2021 | K212548 | LUXEN CL Dental Liquid | EIH Porcelain Powder |
| 31 Oct 2018 | K171585 | LUXEN Zr, LUXEN Smile | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Hiossen Inc. (1), SMD Dental Laboratory (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DENTALMAX CO., LTDFDA reg. 3014980456 | Cheonan-si Chungnam, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058929). 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.