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VITA CAD Temp
FDA UDIClass II (US FDA UDI)
by Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
Identity
- Trade Name
- VITA CAD Temp FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- VITA CAD-Temp multiColor for KaVo ARCTICA, 1M2T, CTM-40, 2 pcs. FDA UDI
- Model / Reference
- EK1M2M402K FDA UDI
- Description
- VITA CAD-Temp multiColor for KaVo ARCTICA, 1M2T, CTM-40, 2 pcs. FDA UDI
Identifiers
- Primary DI / UDI-DI
- J017EK1M2M402K0 FDA UDI
- 510(k) Number
- K070991 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Temporary dental crown/bridge
VITA CAD Temp by Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft — Class II — FDA UDI — listed in FDA GUDID
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Also classified as Temporary dental crown/bridge.
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Cleared under the same submission
K070991 also covers:
- Vita CAD-Temp For Inlab — Institut Straumann SA
- Vita CAD-Temp For Inlab — Institut Straumann SA
- Vita CAD-Temp For Inlab — Institut Straumann SA
- Vita CAD-Temp For Inlab — Institut Straumann SA
- Vita CAD-Temp For Inlab — Institut Straumann SA
- Vita CAD-Temp For Inlab — Institut Straumann SA
- Vita CAD-Temp For Inlab — Institut Straumann SA
- Vita CAD-Temp For Inlab — Institut Straumann SA
- Vita CAD-Temp For Inlab — Institut Straumann SA
- Vita CAD-Temp For Inlab — Institut Straumann SA
- Vita CAD-Temp For Inlab — Institut Straumann SA
- Vita CAD-Temp For Inlab — Institut Straumann SA
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 fd7e29a7-07a7-4933-be38-4e599c7d61c0 35 fields · synced May 30, 2026