Identity
- Trade Name
- Kera Ti5-Disc 98,5 x 18 mm FDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Device Name
- Ti6Al4V based dental alloy for milling, grade 5, Dimension: 98,5 mm x 18 mm FDA UDI
- Model / Reference
- 10045218 FDA UDI
- Description
- Ti6Al4V based dental alloy for milling, grade 5, Dimension: 98,5 mm x 18 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- EDWA100452181 FDA UDI
- FDA Product Code
- EJH FDA UDI
- GMDN Term
- Dental casting non-noble alloy FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3710 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental casting non-noble alloy
Kera Ti5-Disc 98, 5 x 18 mm by Eisenbacher Dentalwaren ED 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
- Eisenbacher Dentalwaren ED GmbH
Sources (1)
- FDA UDI e97d920e-ab62-41b3-9981-2d21e8787227 33 fields · synced May 30, 2026