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Form drill D2- Ø5.4
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref SDSsd470rdModel Form drills
Identity
- Trade Name
- Form drill D2- Ø5.4 EUDAMEDSDS1.2/ SDS2.2 FDA UDI
- Generic Name
- Ceramic dental bur FDA UDI
- Device Name
- Class II form drill for 5.4 FDA UDI
- Model / Reference
- Form drills EUDAMEDSDSsd470rd EUDAMEDFDA UDI
- Description
- Class II form drill for 5.4 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260468252069 EUDAMEDFDA UDI
- Basic UDI-DI
- 426046825TD02PG02C6 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Ceramic dental bur FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Form drill D2- Ø5.4 by SDS Swiss Dental Solutions AG — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 426046825TD02PG02C6 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- SDS Swiss Dental Solutions AG
- EUDAMED SRN
- CH-MF-000019073
- Authorised Representative
- SDS Deutschland GmbH DE-AR-000005774
Sources (2)
- EUDAMED f983cf2f-1587-42dd-a6b0-a7ff1cb7a7a0 61 fields · synced Jun 18, 2026
- FDA UDI 8c8aced5-94fc-4c2f-986f-ed451eaa210f 34 fields · synced May 30, 2026