Identity
- Trade Name
- Vita CAD-Temp For Inlab FDA UDI
- Generic Name
- Custom-made dental crown, polymer FDA UDI
- Device Name
- CARES® single unit restoration, VITA® CAD-Temp® , multiColor xSHADEx FDA UDI
- Model / Reference
- Crowns FDA UDI
- Description
- CARES® single unit restoration, VITA® CAD-Temp® , multiColor xSHADEx FDA UDI
Identifiers
- Catalog Number
- 010.4051 FDA UDI
- Primary DI / UDI-DI
- 07630031744449 FDA UDI
- 510(k) Number
- K070991 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Custom-made dental crown, polymer 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Custom-made dental crown, polymer
Vita CAD-Temp For Inlab by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Custom-made dental crown, polymer.
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
- Ceramill — Vertex-Dental B.V. · Class I
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
- VarseoSmile TriniQ — BEGO Bremer Goldschlägerei Wilh. Herbst GmbH & Co.KG · Class II
- Flexcera™ Smile Ultra+ Bleach — Envisiontec GmbH · Class II
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
- PMMA CAD/CAM Disc — POLIDENT d.o.o. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Institut Straumann SA
Sources (1)
- FDA UDI 5dd06956-6362-46af-994c-5f65bb2402b4 37 fields · synced Jun 8, 2026