Data / Medical devices / South Korea / Dentalmax Co., Ltd
Dentalmax Co., Ltd: FDA-registered device maker in Cheonan-si Chungnam, South Korea, 3 510(k) clearances
Dentalmax Co., Ltd is registered with the FDA (registration 3014980456) in Cheonan-si Chungnam, South Korea. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated September 30, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014980456
- Address
- 50-7, Pungsesandan 2-ro, Pungse-myeon, Dongnam-gu, Cheonan-si Chungnam, South Korea, 31217
- Owner or operator
- DENTALMAX Co., Ltd (10058929)
- Roles
- Manufacturer
- First device listed
- November 12, 2018
- Registered through
- 2026
- Brand names listed
- LUXEN 5G, LUXEN CL Dental Liquid, LUXEN Smile, LUXEN Zr
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 30, 2024 | K241151 | LUXEN 5G | EIH | Substantially Equivalent | Dentalmax Co., Ltd. | accessdata.fda.gov |
| December 6, 2021 | K212548 | LUXEN CL Dental Liquid | EIH | Substantially Equivalent | Dentalmax Co., Ltd. | accessdata.fda.gov |
| October 31, 2018 | K171585 | LUXEN Zr, LUXEN Smile | EIH | Substantially Equivalent | Dentalmax Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 30, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.