Identity
- Trade Name
- LUXEN 5G FDA UDI
- Generic Name
- Dental appliance fabrication material, ceramic FDA UDI
- Model / Reference
- Luxen Smile ML D98 A1 20T FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809900573483 FDA UDI
- 510(k) Number
- K241151 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental appliance fabrication material, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
The LUXEN 5G is a high-quality, dental-grade ceramic implantable material used for creating permanent restorations. It is designed to be used in manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology.
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Cleared under the same submission
K241151 also covers:
- LUXEN 5G — DENTALMAX CO., LTD
- LUXEN 5G — DENTALMAX CO., LTD
- LUXEN 5G — DENTALMAX CO., LTD
- LUXEN 5G — DENTALMAX CO., LTD
- LUXEN 5G — DENTALMAX CO., LTD
- LUXEN 5G — DENTALMAX CO., LTD
- LUXEN 5G — DENTALMAX CO., LTD
- LUXEN 5G — DENTALMAX CO., LTD
- LUXEN 5G — DENTALMAX CO., LTD
- LUXEN 5G — DENTALMAX CO., LTD
- LUXEN 5G — DENTALMAX CO., LTD
- LUXEN 5G — DENTALMAX CO., LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dentalmax Co., Ltd
Sources (1)
- FDA UDI bb991b8f-7ea3-4dae-aaf4-25bb1ff9a644 33 fields · synced Jul 3, 2026