← Back to catalogue
Major Super Lux A1-D4 X6 Lower A1-0/0
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T3011.A1.0/0.LModel Acrylic resin artificial teeth
Identity
- Trade Name
- MAJOR SUPER LUX A1-D4 X6 LOWER A1-0/0 EUDAMEDSUPER LUX A1-D4 X6 LOWER A1-0/0 FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- Major Plus, Major Super Lux, Major Dent, Bambino tooth EUDAMEDSUPER LUX A1-D4 , SIX ARTIFICIAL TEETH, LOWER, SHADE A1, MOULD 0/0 FDA UDI
- Model / Reference
- Acrylic resin artificial teeth EUDAMEDT3011.A1.0/0.L EUDAMEDShade A1, Mould 0/0 FDA UDI
- Description
- SUPER LUX A1-D4 , SIX ARTIFICIAL TEETH, LOWER, SHADE A1, MOULD 0/0 FDA UDI
Identifiers
- Catalog Number
- T3011 FDA UDI
- Primary DI / UDI-DI
- 08056640029095 EUDAMEDFDA UDI
- Basic UDI-DI
- 8056640TEEGF EUDAMED
- Direct Marketing DI
- 08056640029095 EUDAMED
- FDA Product Code
- ELM FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Resin artificial teeth FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3590 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
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Major Super Lux A1-D4 X6 Lower A1-0/0 by Major Prodotti Dentari S.p.a. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8056640TEEGF | 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
- Major Prodotti Dentari S.p.A.
- EUDAMED SRN
- IT-MF-000024700
Sources (2)
- EUDAMED ce54eed3-9af3-43f6-9a7a-772220fa1316 61 fields · synced Oct 6, 2026
- FDA UDI 4438ebaa-638d-42ce-b9d1-3e32fac0a8eb 35 fields · synced May 29, 2026