VITA VIONIC® DENT RESIN B1 1000g
FDA UDIEUDAMEDClass II (US FDA UDI)
by DETAX GmbH
Identity
- Trade Name
- VITA VIONIC® DENT RESIN B1 1.000 g; EUDAMEDVITA VIONIC® DENT RESIN B1 1000g FDA UDI
- Generic Name
- Dental appliance fabrication material, resin FDA UDI
- Model / Reference
- 04593 EUDAMEDFDA UDIDental Restoration Material EUDAMED
Identifiers
- Primary DI / UDI-DI
- +EDET045931 EUDAMEDEDET045931 FDA UDI
- Basic UDI-DI
- ++EDET0996K EUDAMED
- FDA Product Code
- EBF FDA UDIEBG FDA UDIPZY FDA UDI
- EMDN Code
- Q0102050199 DENTISTRY RESINS - OTHER EUDAMED
- GMDN Term
- Dental appliance fabrication material, resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI872.3770 FDA UDI872.3590 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
Yes
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Dental appliance fabrication material, resin
VITA VIONIC® DENT RESIN B1 1000g by DETAX GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Dental appliance fabrication material, resin.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DETAX GmbH
Sources (2)
- FDA UDI caf17ab9-f004-4518-845f-e87226a58636 33 fields · synced Jul 23, 2026
- EUDAMED 4c83fbac-0583-4715-b664-d05ff33700ed 61 fields · synced Jul 23, 2026