← Back to catalogue
Major.repair Liquid - 10x 500ml
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref C3100Model Cold-curing denture base acrylic resin
Identity
- Trade Name
- MAJOR.REPAIR LIQUID - 10X 500ML EUDAMED
- Device Name
- MAJOR.REPAIR EUDAMED
- Model / Reference
- Cold-curing denture base acrylic resin EUDAMEDC3100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08056640078666 EUDAMED
- Basic UDI-DI
- 8056640REPGT 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.repair Liquid - 10x 500ml by Major Prodotti Dentari S.p.a. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K082153 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8056640REPGT | Class IIa | Active |
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 dcd50e82-0e91-4b5b-8983-3fb8f3f5d11b 61 fields · synced Jun 18, 2026
- FDA 510(k) K082153 1 fields · synced May 18, 2026