Identity
- Trade Name
- Starbond Ti5 Disc EUDAMEDStarbond Ti5 FDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Device Name
- Starbond Ti5 Disc (12 mm; ohne Absatz) EUDAMEDDisc, 12 mm ø 99.5 mm / without edging FDA UDI
- Model / Reference
- 136012 EUDAMEDFDA UDI
- Description
- Disc, 12 mm ø 99.5 mm / without edging FDA UDI
Identifiers
- Catalog Number
- 136012 FDA UDI
- Primary DI / UDI-DI
- 04260207850792 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260207850792 EUDAMED
- FDA Product Code
- EJH FDA UDI
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMED
- GMDN Term
- Dental casting non-noble alloy FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3710 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Starbond Ti5 Disc by Scheftner GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04260207850792 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Scheftner GmbH
- EUDAMED SRN
- DE-MF-000049419
Sources (2)
- EUDAMED 6f878548-0a73-4a62-9374-4adb2a7eb3b9 61 fields · synced Aug 2, 2026
- FDA UDI d0af4aa7-a663-44bd-b01a-4dc67c23ccb3 34 fields · synced May 30, 2026