Identity
- Trade Name
- Abro Basic Mono B2 95H18 FDA UDI
- Generic Name
- Dental bridge, polymer FDA UDI
- Device Name
- Content: 1 piece Height: 18 mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. Specifically designed for the production of denture teeth, long-term temporaries as well as secondary and tertiary structures. FDA UDI
- Model / Reference
- DSAL9518B02 FDA UDI
- Description
- Content: 1 piece Height: 18 mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. Specifically designed for the production of denture teeth, long-term temporaries as well as secondary and tertiary structures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D800DSAL9518B020 FDA UDI
- FDA Product Code
- EBI FDA UDI
- GMDN Term
- Dental bridge, polymer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3760 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental bridge, polymer
Abro Basic Mono B2 95H18 by Zirkonzahn GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Try-In I — Zirkonzahn GmbH · Class II
- Temp Premium Flexible — 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 |
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Manufacturer
- Manufacturer
- Zirkonzahn GmbH
Sources (1)
- FDA UDI 50dd64bd-c7e3-4f29-b3ab-49647f3c0a49 34 fields · synced May 30, 2026