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Vita Enamic Stains
FDA UDIClass II (US FDA UDI)
by Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
Identity
- Trade Name
- VITA ENAMIC STAINS FDA UDI
- Generic Name
- Dental prosthesis veneer resin FDA UDI
- Device Name
- VITA ENAMIC STAIN 6, black, 2 g FDA UDI
- Model / Reference
- EENST062 FDA UDI
- Description
- VITA ENAMIC STAIN 6, black, 2 g FDA UDI
Identifiers
- Primary DI / UDI-DI
- J017EENST0620 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental prosthesis veneer resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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
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
Category: Dental prosthesis veneer resin
Vita Enamic Stains by Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Dental prosthesis veneer resin.
- Defend — Young Innovations, Inc. · Class II
- Ceramage — SHOFU DENTAL CORP. · Class II
- CERAMAGE — SHOFU DENTAL CORP. · Class II
- Ceramill — Vertex-Dental B.V. · Class I
- Signum composite flow — Kulzer, Inc. · Class II
- Solidex — SHOFU DENTAL CORP. · Class II
- Universal Opaque — SHOFU DENTAL CORP. · Class II
- Universal Opaque — SHOFU DENTAL CORP. · Class II
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
Sources (1)
- FDA UDI a89440ac-308e-4190-a577-d68d69e7d6e4 34 fields · synced Jun 1, 2026