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DENTALMAX 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/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +82415233580
PRRC Contact: Seung bum Park
EUDAMED SRN: KR-MF-000014617
FDA FEI Number: 3014980456
DUNS Number: 688528450

Catalogue (6435)

Page 84 of 129

Device	Model / Reference	Registries	Class	Status
LUXEN Smile, LUXEN Zr	ML 1200 600 Multi P D98 C1 30T	FDA UDI	Class II	Active
Luxen Zr	G44PD_9814_BL3	FDA UDI	Class II	Active
LUXEN Smile, LUXEN Zr	ML 1200 600 Multi P D98 B4 25T	FDA UDI	Class II	Active
Luxen Cl	Luxen CL-MB1 50ml	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile ML D98 A3.5 14T	FDA UDI	Class II	Active
Luxen 5g	Luxen Zr D98 D4 12T	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile D98 A3 14T	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile D98 C3 12T	FDA UDI	Class II	Active
Luxen 5g	Luxen Enamel D98 A3 10T	FDA UDI	Class II	Active
Luxen Cl	Luxen CL-02 10ml	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile P D98 A1 20T	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile ML D95 MBL3 20T	FDA UDI	Class II	Active
LUXEN Smile	Galaxy Clear 95 MD2-16T	FDA UDI	Class II	Active
LUXEN Smile, LUXEN Zr	ML 1200 600 Multi P D95 C4 22T	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile G D95 A1 30T	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile G D95 SBL3 25T	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile ML D95 MBL1 20T	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile ML D95 B3 22T	FDA UDI	Class II	Active
Luxen 5g	Luxen ML D95 B4 18T	FDA UDI	Class II	Active
Luxen Cl	Luxen CL-Cervical C 50ml	FDA UDI	Class II	Active
LUXEN Smile, LUXEN Zr	Multi D95 C1 12T	FDA UDI	Class II	Active
Luxen 5g	Luxen ML D95 Light 28T	FDA UDI	Class II	Active
Luxen 5g	Luxen Zr D95 B3 25T	FDA UDI	Class II	Active
LUXEN Zr	Galaxy Clear 95 MC1-20T	FDA UDI	Class II	Active
LUXEN Smile, LUXEN Zr	ML 1200 600 Multi P D98 C3 22T	FDA UDI	Class II	Active
Luxen 5g	Luxen Enamel D98 D2 20T	FDA UDI	Class II	Active
LUXEN Smile, LUXEN Zr	En D98 A2 20T	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile G D98 D3 20T	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile P D95 B3 10T	FDA UDI	Class II	Active
Luxen 5g	Luxen Enamel GB D95 A1 14T	FDA UDI	Class II	Active
Luxen 5g	Luxen ML D95 Dark 14T	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile P D98 A2 28T	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile D98 A4 20T	FDA UDI	Class II	Active
Luxen 5g	Luxen Enamel GB D98 C4 30T	FDA UDI	Class II	Active
Luxen 5g	Luxen Zr D95 B2 20T	FDA UDI	Class II	Active
Luxen 5g	Luxen ML D98 B1 28T	FDA UDI	Class II	Active
Luxen 5g	Luxen ML D98 MBL1 22T	FDA UDI	Class II	Active
LUXEN Smile	LUXEN Smile-18T-D98-MB2	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile G D95 D3 20T	FDA UDI	Class II	Active
LUXEN Smile, LUXEN Zr	ML 1200 600 Multi P D95 B2 22T	FDA UDI	Class II	Active
Luxen Cl	Luxen CL-Gingiva 1 100ml	FDA UDI	Class II	Active
LUXEN Smile, LUXEN Zr	ML 1200 600 Multi P D98 MHT Dark 16T	FDA UDI	Class II	Active
LUXEN Zr	LUXEN Smile-20T-D95-MA1	FDA UDI	Class II	Active
LUXEN Smile	LUXEN Smile-14T-D98-MC2	FDA UDI	Class II	Active
LUXEN Smile, LUXEN Zr	ML 1200 600 Multi P D95 B1 18T	FDA UDI	Class II	Active
LUXEN Smile	LUXEN Smile-25T-D95-MC1	FDA UDI	Class II	Active
LUXEN Smile, LUXEN Zr	Multi D95 A4 12T	FDA UDI	Class II	Active
LUXEN Smile, LUXEN Zr	Multi D98 A3 30T	FDA UDI	Class II	Active
LUXEN Zr	LUXEN 1100-22T-D98-MA2	FDA UDI	Class II	Active
Luxen 5g	Luxen Smile GL D98 SBL2 30T	FDA UDI	Class II	Active

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