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Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- WIELAND ZENO CAO TEMPORARY PMMA DISC, TOOTH-COLORED FDA UDI
- Generic Name
- Dental bridge, polymer FDA UDI
- Device Name
- PMMA finished full-arch restoration FDA UDI
- Model / Reference
- Bridges (tooth borne) FDA UDI
- Description
- PMMA finished full-arch restoration FDA UDI
Identifiers
- Catalog Number
- 010.4118 FDA UDI
- Primary DI / UDI-DI
- 07630031749000 FDA UDI
- 510(k) Number
- K071548 FDA UDI
- FDA Product Code
- EBG FDA UDI
- GMDN Term
- Dental bridge, 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: Dental bridge, polymer
Wieland Zeno Cao Temporary Pmma Disc, Tooth-Colored by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K071548 also covers:
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- CORiTEC PMMA Disc — Merz Dental GmbH
- Ceramill TEMP — Merz Dental GmbH
- Ceramill TEMP — Merz Dental GmbH
- Ceramill TEMP — Merz Dental GmbH
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 879e2c5d-998a-4031-bd36-8377e470cfba 36 fields · synced May 30, 2026