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Major Dent New X8 Upper 1r-52
EUDAMEDClass IIa (EU MDR)
Ref T4142.1R.52.UModel Acrylic resin artificial teeth
Identity
- Trade Name
- MAJOR DENT NEW X8 UPPER 1R-52 EUDAMED
- Device Name
- Major Plus, Major Super Lux, Major Dent, Bambino tooth EUDAMED
- Model / Reference
- Acrylic resin artificial teeth EUDAMEDT4142.1R.52.U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056640043145 EUDAMED
- Basic UDI-DI
- 8056640TEEGF EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Major Dent New X8 Upper 1r-52 by Major Prodotti Dentari S.p.a. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8056640TEEGF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Major Prodotti Dentari S.p.A.
- EUDAMED SRN
- IT-MF-000024700
Sources (1)
- EUDAMED 70a6e557-f4a5-4f41-8433-25ee8fa1a269 61 fields · synced Aug 1, 2026