Identity
- Trade Name
- Flexcera™ Smile Ultra+ A2 FDA UDI
- Generic Name
- Temporary dental crown/bridge resin FDA UDI
- Device Name
- Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges. FDA UDI
- Model / Reference
- RES-01-3147 FDA UDI
- Description
- Flexcera™ Smile Ultra+ is a light-curing material for the additive manufacturing of permanent single and partial crowns, of artificial teeth, of veneers and of monolithic full and partial dentures and temporary crowns and bridges. FDA UDI
Identifiers
- Catalog Number
- RES-01-3147 FDA UDI
- Primary DI / UDI-DI
- 04260683220416 FDA UDI
- FDA Product Code
- EBG FDA UDIPZY FDA UDIELM FDA UDIEBF FDA UDIEBI FDA UDI
- GMDN Term
- Temporary dental crown/bridge resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3770 FDA UDI872.3590 FDA UDI872.3690 FDA UDI872.3760 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Partial dentureResin artificial teethTemporary dental crown/bridge resinCustom-made dental crown, polymer
Flexcera™ Smile Ultra+ A2 by Envisiontec GmbH — 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
- Envisiontec GmbH
Sources (1)
- FDA UDI 4decfe30-5e6c-413f-b7a8-52b1b32ccbac 36 fields · synced May 30, 2026