Identity
- Trade Name
- Tizian Blank Zirconia Reinforced Composite A4 FDA UDI
- Generic Name
- Dental bridge, polymer FDA UDI
- Device Name
- Milling blank made from high performance acrylic and zirconium dioxide which combines the qualities of both materials. The elastic and mildly flexible material ensures permanent restorations with up to 3 units (single crowns, inlays, onlays, veneers, three-unit bridges) as well as long-term temporaries with up to 16 units and a life span of up to two years. FDA UDI
- Model / Reference
- 220114 FDA UDI
- Description
- Milling blank made from high performance acrylic and zirconium dioxide which combines the qualities of both materials. The elastic and mildly flexible material ensures permanent restorations with up to 3 units (single crowns, inlays, onlays, veneers, three-unit bridges) as well as long-term temporaries with up to 16 units and a life span of up to two years. FDA UDI
Identifiers
- Primary DI / UDI-DI
- ESDG2201141 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental bridge, polymer
Tizian Blank Zirconia Reinforced Composite A4 by Schütz Dental GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental bridge, polymer.
- Try-In I — Zirkonzahn GmbH · Class II
- Abro Basic Multistratum A2-A3 125H10 — Zirkonzahn GmbH · Class II
- Abro Basic Mono C2-C3 98H18 — Zirkonzahn GmbH · Class II
- Abro Basic Mono B2-B3 98H14 — Zirkonzahn GmbH · Class II
- Try-In I — Zirkonzahn GmbH · Class II
- Temp Premium Flexible — Zirkonzahn GmbH · Class II
- Abro Basic Mono A2 125H15 — Zirkonzahn GmbH · Class II
- Abro Basic Mono A2-A3 95H27 — Zirkonzahn GmbH · Class II
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
- Schütz Dental GmbH
Sources (1)
- FDA UDI 32a3e2cf-c089-4cdb-a5d8-8838b53c3c1d 34 fields · synced Jun 8, 2026