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Major Plus Comp V X6 Upper A1-B2-
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref T2031.A1.B2.UModel Multilayer composite and acrylic resin artificial teeth
Identity
- Trade Name
- MAJOR PLUS COMP V X6 UPPER A1-B2- EUDAMEDMAJOR PLUS COMP V X6 UPPER A1-B2 FDA UDI
- Generic Name
- Resin artificial teeth FDA UDI
- Device Name
- Major Plus Comp, AF Comp EUDAMEDMAJOR PLUS COMP V , SIX ARTIFICIAL TEETH, UPPER, SHADE A1, MOULD B2 FDA UDI
- Model / Reference
- Multilayer composite and acrylic resin artificial teeth EUDAMEDT2031.A1.B2.U EUDAMEDShade A1, Mould B2 FDA UDI
- Description
- MAJOR PLUS COMP V , SIX ARTIFICIAL TEETH, UPPER, SHADE A1, MOULD B2 FDA UDI
Identifiers
- Catalog Number
- T2031 FDA UDI
- Primary DI / UDI-DI
- 08056640000018 EUDAMEDFDA UDI
- Basic UDI-DI
- 8056640CMPF8 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 Plus Comp V X6 Upper A1-B2- 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 | 8056640CMPF8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Major Prodotti Dentari S.p.A.
- EUDAMED SRN
- IT-MF-000024700
Sources (2)
- EUDAMED bb6a52b6-d700-4bc2-bd51-db4dbe3d626e 61 fields · synced May 30, 2026
- FDA UDI 146498ef-255b-495b-a066-24e161e02d5d 35 fields · synced May 30, 2026