Major Dent New-V X8 Lower C2-68A
by Major Prodotti Dentari S.p.A.
Ref T4112.C2.68A.LModel Acrylic resin artificial teeth
Active
CE MDR
Valid until
18 Apr 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8056640TEEGF 08056640052666 | Date5 Feb 2026 | StatusActive |
Certificates
- 0425-MDR-030075-01 Active
Quality management system EU MDR
- Certifier
- ICIM S.P.A. 0425
- Issued
- 12 May 2025
- Expires
- 18 Apr 2029
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
- Austria
- Belgium
- Bulgaria
- Croatia
- Cyprus
- Czechia
- Denmark
- Estonia
- Finland
- France
- Germany
- Greece
- Hungary
- Iceland
- Ireland
- Italy
- Latvia
- Liechtenstein
- Lithuania
- Luxembourg
- Malta
- Netherlands
- Northern Ireland
- Norway
- Poland
- Portugal
- Romania
- Slovakia
- Slovenia
- Spain
- Sweden
- Türkiye
Specification
- Device Name
- Major Plus, Major Super Lux, Major Dent, Bambino tooth
- Model / Reference
- Acrylic resin artificial teeth, T4112.C2.68A.L
- Primary DI / UDI-DI
- 08056640052666
- Basic UDI-DI
- 8056640TEEGF
- EMDN Code
- Q010699 Materials for the preparation of custom-made dental devices - other
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000024700
Other devices from Major Prodotti Dentari S.P.A.
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No