Identity
- Trade Name
- SI-923 EUDAMEDImplantmed SI-923 DSI FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Device Name
- Motor control units - Stand Alone OCI EUDAMEDSurgical Unit FDA UDI
- Model / Reference
- 30286001 EUDAMED30286003 FDA UDI
- Description
- Surgical Unit FDA UDI
Identifiers
- Primary DI / UDI-DI
- +J021302860011 EUDAMEDJ021302860031 FDA UDI
- Basic UDI-DI
- ++J021S0006RC EUDAMED
- Direct Marketing DI
- +J021302860010 EUDAMED
- FDA Product Code
- EBW FDA UDI
- EMDN Code
- Z12119099 VARIOUS DENTAL STOMATOLOGY INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Surgical power tool system control unit, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Surgical power tool system control unit, line-powered
Implantmed SI-923 DSI by W & H Dentalwerk Bürmoos GmbH — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- W & H Dentalwerk Bürmoos GmbH
Sources (2)
- FDA UDI bc99ff15-5447-4682-91e1-04737d70e7d4 33 fields · synced Jul 8, 2026
- EUDAMED e3d005d5-0b3a-4867-906e-4845f4acc88e 61 fields · synced Jul 8, 2026