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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 93 of 129| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Luxen Smile | M45PD_9825_BL2 | FDA UDI | Class II | Active |
| LUXEN Smile, LUXEN Zr | Multi D95 A4 16T | FDA UDI | Class II | Active |
| LUXEN Smile | LUXEN Smile-12T-D95-S2 | FDA UDI | Class II | Active |
| LUXEN Smile | LUXEN Smile-12T-D95-MB1 | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile G D98 SBL3 10T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel G D98 B3 30T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile ML D95 A4 25T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile GL D95 D3 28T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel G D95 C2 28T | FDA UDI | Class II | Active |
| LUXEN Smile | Luxen Smile SE Mulit-12T-D98-A3 | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel G D95 BL3 14T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile G D95 A3 18T | FDA UDI | Class II | Active |
| LUXEN Smile | Galaxy Clear 98 MC1-30T | FDA UDI | Class II | Active |
| LUXEN Zr | LUXEN 1100-12T-D98-MB3 | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile D98 A3.5 28T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D95 B1 28T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile G D98 SBL2 30T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile G D95 B3 10T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel G D95 D4 22T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile GL D95 D3 25T | FDA UDI | Class II | Active |
| Luxen Smile | M35PD_9812_BLW | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile ML D95 C3 14T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel D98 B1 18T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel G D95 D4 25T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel G D95 BL1 28T | FDA UDI | Class II | Active |
| LUXEN Smile, LUXEN Zr | ML 1200 600 Multi P D98 A2 20T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel B65 E1 | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D98 C1 14T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D98 B4 20T | FDA UDI | Class II | Active |
| LUXEN Zr | Galaxy Zr 98 A2-30T | FDA UDI | Class II | Active |
| LUXEN Zr | LUXEN 1100-22T-D95-MC4 | FDA UDI | Class II | Active |
| LUXEN Smile | Luxen Smile SE Mulit-22T-D98-B1 | FDA UDI | Class II | Active |
| LUXEN Smile | Galaxy Clear 98 MC3-25T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile GL D95 C2 25T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile G D98 A4 30T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile GL D98 A4 25T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile G D95 A3.5 30T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Zr D95 C2 20T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile D98 SMS3 20T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel D95 E2 28T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile P D95 A4 25T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Smile G D98 C3 16T | FDA UDI | Class II | Active |
| Luxen 5g | Luxen Enamel GB D95 B1 30T | FDA UDI | Class II | Active |
| LUXEN Zr | LUXEN 1100-30T-D98-MC3 | FDA UDI | Class II | Active |
| LUXEN Zr | LUXEN 1100-16T-D98-MB4 | FDA UDI | Class II | Active |
| Luxen Cl | Luxen CL-CCV1 100ml | FDA UDI | Class II | Active |
| LUXEN Smile, LUXEN Zr | En D95 A1 18T | FDA UDI | Class II | Active |
| LUXEN Smile | Luxen Smile SE Mulit-20T-D98-B4 | FDA UDI | Class II | Active |
| LUXEN Smile, LUXEN Zr | En D98 A2 25T | FDA UDI | Class II | Active |
| LUXEN Zr | Galaxy Zr 95 E1 -10T | FDA UDI | Class II | Active |
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