Identity
- Trade Name
- VITA VIONIC BASE DISC HI FDA UDI
- Generic Name
- Dental appliance fabrication material, thermoplastic FDA UDI
- Device Name
- VITA VIONIC BASE DISC HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures. VITA VIONIC BASE DISC HI is suitable for longterm use in the oral cavity up to 10 years. FDA UDI
- Model / Reference
- soft pink Ø98.5xh30mm FDA UDI
- Description
- VITA VIONIC BASE DISC HI are pre-colored dental milling blanks made of impact-resistant PMMA for the manufacture of denture bases for removable dentures. VITA VIONIC BASE DISC HI is suitable for longterm use in the oral cavity up to 10 years. FDA UDI
Identifiers
- Catalog Number
- ADSOP9830 FDA UDI
- Primary DI / UDI-DI
- EDDIADSOP98301 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental appliance fabrication material, thermoplastic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Height — 30 Millimeter FDA UDIOuter Diameter — 98.5 Millimeter FDA UDI
Category: Dental appliance fabrication material, thermoplastic
Vita Vionic Base Disc Hi by Dental Direkt GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dental Direkt GmbH
Sources (1)
- FDA UDI 3fbcf84b-77ec-4852-b8a0-757195958247 36 fields · synced Jun 6, 2026