← Back to catalogue
Starbond Easy Disc (8 mm +1 more model
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 140008Model Starbond Easy Disc
Identity
- Trade Name
- TEST EUDAMEDStarbond Easy FDA UDI
- Generic Name
- Dental casting non-noble alloy FDA UDI
- Device Name
- Starbond Easy Disc (8 mm; ohne Absatz) EUDAMEDDisc, 8 mm ø 99,5 mm / without edging FDA UDI
- Model / Reference
- 140008 EUDAMEDFDA UDIStarbond Easy Disc EUDAMED
- Description
- Disc, 8 mm ø 99,5 mm / without edging FDA UDI
Identifiers
- Catalog Number
- 140008 FDA UDI
- Primary DI / UDI-DI
- 04260207854103 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04260207854103 EUDAMED426020785CoCrW-mill9X EUDAMED
- FDA Product Code
- EJH FDA UDI
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMED
- GMDN Term
- Dental casting non-noble alloy FDA UDI
- Models / Variants
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 Easy Disc (8 mm +1 more model by Scheftner GmbH — Class IIa — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — 2 models
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-04260207854103 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-04260207854103 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scheftner GmbH
- EUDAMED SRN
- DE-MF-000049419
Sources (3)
- EUDAMED ab96728f-6bae-4748-a9ed-bb3ae6a3860e 61 fields · synced Jul 10, 2026
- EUDAMED 0a9d5123-f46c-4ecf-aef8-2b637a17b887 61 fields · synced May 19, 2026
- FDA UDI 6e20aa96-25a7-4d2c-bf7d-318775d20e9b 34 fields · synced May 29, 2026