Identity
- Trade Name
- LUXEN EUDAMEDLUXEN Smile, LUXEN Zr FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Device Name
- Dental ceramic block EUDAMED
- Model / Reference
- En D98 A1 10T EUDAMEDFDA UDILuxen Zr EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800046921329 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800046921329 EUDAMED
- 510(k) Number
- K171585 FDA UDI
- FDA Product Code
- EIH FDA UDI
- EMDN Code
- Q01010199 DENTAL RESTORATION DEVICES - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental appliance fabrication material, ceramic
Luxen by Dentalmax Co., Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental appliance fabrication material, ceramic.
- Razor / MegaPlus — U&C International Co., Ltd · Class II
- rainbow High shine — Genoss · Class II
- Bloomden — Bloomden Bioceramics (Hunan) Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- Multi M Series — DMAX Co., Ltd. · Class II
- BruxZir Shaded 16 PLUS — PRISMATIK DENTALCRAFT, INC. · Class II
- CGI — CERAGROUP INDUSTRIES · Class II
- ARENA Star — ARUM DENTISTRY Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800046921329 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DENTALMAX Co., LTD
- EUDAMED SRN
- KR-MF-000014617
- Authorised Representative
- Certification Experts NL-AR-000000235
Sources (2)
- EUDAMED fe04b68b-ceb0-4edb-a489-008e08f7caeb 61 fields · synced Jul 22, 2026
- FDA UDI 62c5009a-d5bc-49cf-87f7-f3559282fd60 33 fields · synced May 30, 2026