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VITA VIONIC® BASE RESIN IMPACT pink-translucent 1000g
FDA UDIEUDAMEDClass II (US FDA UDI)
by DETAX GmbH
Identity
- Trade Name
- VITA VIONIC® BASE RESIN IMPACT pink-translucent 1000g FDA UDI
- Generic Name
- Denture reliner, elastic, long-term FDA UDI
- Model / Reference
- 04586 FDA UDI
Identifiers
- Primary DI / UDI-DI
- EDET045861 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Denture reliner, elastic, long-term 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Denture reliner, elastic, long-term
VITA VIONIC® BASE RESIN IMPACT pink-translucent 1000g by DETAX GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Denture reliner, elastic, long-term.
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- Sofreliner Tough — TOKUYAMA DENTAL CORPORATION · Class II
- PROVISA — BENCO DENTAL SUPPLY CO. · Class II
- Tuf-Link II — Dentatus AB · Class II
- Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLC · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 de9e4e61-9ad7-4ed7-8830-011e37251ae3 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026