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Straumann Variobase Abutment / IPS e.max CAD restorations
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Straumann Variobase Abutment / IPS e.max CAD restorations FDA UDI
- Generic Name
- Dental bridge, ceramic FDA UDI
- Device Name
- Straumann CARES 16-unit bridge made of, 3M ESPE Lava Plus Zirconia, XshadeX FDA UDI
- Model / Reference
- Bridges (tooth borne) FDA UDI
- Description
- Straumann CARES 16-unit bridge made of, 3M ESPE Lava Plus Zirconia, XshadeX FDA UDI
Identifiers
- Catalog Number
- 010.0046 FDA UDI
- Primary DI / UDI-DI
- 07630031701657 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental bridge, ceramic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental bridge, ceramic
Straumann Variobase Abutment / IPS e.max CAD restorations by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Manufacturer
- Institut Straumann SA
Sources (1)
- FDA UDI 87d32fae-c19c-471f-98e9-6c4e3e35bc35 35 fields · synced Jun 1, 2026