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Dental Model Model V1.0-Y
EUDAMEDFDA UDIClass I (EU MDR)
Ref Model V1.0-YModel Model V1.0-G/Model V1.0-Y/Model W1.0-B/Model H1.0-G/Model H1.0-Y/Model S1.0-G/Model S1.0-Y
Identity
- Trade Name
- Dental Model Model V1.0-Y EUDAMEDRiton FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Device Name
- Dental Model EUDAMED
- Model / Reference
- Model V1.0-G/Model V1.0-Y/Model W1.0-B/Model H1.0-G/Model H1.0-Y/Model S1.0-G/Model S1.0-Y EUDAMEDModel V1.0-Y EUDAMEDV3.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06975902950118 EUDAMEDFDA UDI
- Basic UDI-DI
- 697590295RXT02WT EUDAMED
- FDA Product Code
- EBH FDA UDI
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3670 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dental Model Model V1.0-Y by Riton 3D Technology Co., Ltd — Class I — 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 | 697590295RXT02WT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Riton 3D Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000044171
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 0adae79c-5043-4d0d-8ad2-9e96f11c1258 61 fields · synced Jun 18, 2026
- FDA UDI 59ba96c3-fc14-4662-9557-5e96394f207b 32 fields · synced May 29, 2026