Identity
- Trade Name
- Kera®starSplint Bio FDA UDI
- Generic Name
- Custom-made dental crown, polymer FDA UDI
- Device Name
- Kera®starSplint Bio Co-polymer for the production of therapeutic splints 98.0 x 16 mm FDA UDI
- Model / Reference
- 11051216 FDA UDI
- Description
- Kera®starSplint Bio Co-polymer for the production of therapeutic splints 98.0 x 16 mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- EDWA110512161 FDA UDI
- FDA Product Code
- IQM FDA UDI
- GMDN Term
- Custom-made dental crown, polymer FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3025 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Custom-made dental crown, polymer
Kera®starSplint Bio by Eisenbacher Dentalwaren ED GmbH — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Eisenbacher Dentalwaren ED GmbH
Sources (1)
- FDA UDI 035e10dc-3777-43d8-98ec-0ec0f10316c4 33 fields · synced Jun 7, 2026