Is this your brand? Sign in to claim ownership.
Sign in to claim this brandDENTALMAX CO., LTD
South Korea·KR-MF-000014617
Last updated September 17, 2026
What DENTALMAX CO., LTD makes
Dentalmax Co., Ltd manufactures dental appliance fabrication materials made of ceramic, including products such as Luxen Smile, Luxen 5G, Luxen CL, and Luxen Zr.
These devices are classified as Class II and are listed in the FDA UDI registry. The company is based in South Korea (KR).
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of dental devices does Dentalmax Co., Ltd manufacture?
Dentalmax Co., Ltd produces dental appliance fabrication materials that are made of ceramic. The product line includes items such as Luxen Smile, Luxen 5G, Luxen CL, and Luxen Zr, all of which are intended for creating dental appliances rather than being finished prostheses themselves.
Where is Dentalmax Co., Ltd headquartered?
The company is based in South Korea, as indicated by the country code KR in the provided data. This location determines the regulatory environment the company operates under and may affect where its devices are marketed.
In which regulatory registry are Dentalmax’s devices listed?
Dentalmax’s ceramic dental fabrication materials are listed in the FDA UDI (Unique Device Identification) registry. This means each device has a unique identifier recorded with the U.S. Food and Drug Administration, allowing traceability and compliance with U.S. regulations.
How are Dentalmax’s devices classified under regulatory rules?
All of the listed devices—Luxen Smile, Luxen 5G, Luxen CL, and Luxen Zr—are classified as Class II medical devices. Class II classification indicates a moderate level of risk and typically requires special controls in addition to general controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- South Korea
- Address
- 50-7, Pungsesandan 2-ro, Pungse-myeon, Dongnam-gu, Cheonan-si,, Chungcheongnam-do, South Korea
- Website
- dentalmax.co.kr/
- —
- —
- [email protected]
- Phone
- +82415233580
- PRRC Contact
- Seung bum Park
- EUDAMED SRN
- KR-MF-000014617
- FDA FEI Number
- 3014980456
- DUNS Number
- 688528450
Catalogue (6435)
Page 78 of 129| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LUXEN Smile, LUXEN Zr | ML 600 D98 A3 12T | FDA UDI | Class II | Active |
| Luxen Cl | Luxen CL-0315 50ml | FDA UDI | Class II | Active |
| Luxen Cl | Luxen CL-MC4 30ml | FDA UDI | Class II | Active |
| Luxen Cl | Luxen CL-2025 100ml | FDA UDI | Class II | Active |
| LUXEN Smile | Galaxy Clear 95 MC2-25T | FDA UDI | Class II | Active |
| LUXEN Smile, LUXEN Zr | Multi D95 D4 16T | FDA UDI | Class II | Active |
| LUXEN Smile, LUXEN Zr | En D95 A4 22T | FDA UDI | Class II | Active |
| LUXEN Zr | LUXEN Zr-16T-D98-E4 | FDA UDI | Class II | Active |
| LUXEN Smile, LUXEN Zr | ML 1200 600 Multi P D98 D2 20T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel D95 E3 10T | FDA UDI | Class II | Active |
| LUXEN Smile, LUXEN Zr | Multi D98 A1 18T | FDA UDI | Class II | Active |
| LUXEN Smile | Luxen Smile SE Mulit-25T-D98-D4 | FDA UDI | Class II | Active |
| LUXEN Smile | LUXEN Smile-14T-D98-MC3 | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile P D98 A2 18T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen ML D95 MBL3 14T | FDA UDI | Class II | Active |
| Luxen Cl | Luxen CL-B1D 100ml | FDA UDI | Class II | Active |
| Luxen 5g | Luxen ML D95 C2 25T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D98 D3 14T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D98 B1 16T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D95 A3.5 16T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel D98 A3.5 16T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D98 B3 20T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile D95 SMS2 28T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel D95 B4 25T | FDA UDI | Class II | Active |
| LUXEN Smile, LUXEN Zr | ML 1200 600 Multi P D98 B4 18T | FDA UDI | Class II | Active |
| LUXEN Smile, LUXEN Zr | ML 1200 600 Multi P D95 B3 14T | FDA UDI | Class II | Active |
| LUXEN Smile, LUXEN Zr | Multi D95 A1 30T | FDA UDI | Class II | Active |
| LUXEN Smile, LUXEN Zr | ML 600 D95 A3 16T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D98 B2 22T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile P D95 C4 18T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile ML D95 D3 22T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile D95 C2 14T | FDA UDI | Class II | Active |
| Luxen Smile | M45PD_9812_BL1 | FDA UDI | Class II | Active |
| LUXEN Zr | LUXEN 1100-25T-D98-MB4 | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D95 C1 22T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D95 S2 20T | FDA UDI | Class II | Active |
| Luxen Cl | Luxen CL-11 30ml | FDA UDI | Class II | Active |
| Luxen Cl | Luxen CL-Enamel 3 50ml | FDA UDI | Class II | Active |
| Luxen Smile | M45PD_9818_BL2 | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile D98 SMS2 25T | FDA UDI | Class II | Active |
| Luxen Cl | Luxen CL-MA3.5 30ml | FDA UDI | Class II | Active |
| Luxen 5g | Luxen ML D95 C1 20T | FDA UDI | Class II | Active |
| LUXEN Smile | LUXEN Smile-22T-D95-MC3 | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile ML D95 MBL2 22T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile P D98 B4 20T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D95 B4 16T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen ML D95 A1 22T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D98 A3.5 20T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel GB D98 A3 16T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile ML D98 D2 12T | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.