Identity
- Trade Name
- MB-302 FDA UDI
- Generic Name
- Dental handpiece maintenance unit FDA UDI
- Device Name
- Assistina TWIN FDA UDI
- Model / Reference
- 30310000 FDA UDI
- Description
- Assistina TWIN FDA UDI
Identifiers
- Primary DI / UDI-DI
- J021303100001 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental handpiece maintenance unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental handpiece maintenance unit
Mb-302 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
European Union Unknown
MDR
United States Pending data
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 16cb8d5b-eaa9-464c-a72c-96a7ab3722f3 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026