Identity
- Trade Name
- Proxeo ULTRA Handpiece PB-5 L Q FDA UDI
- Generic Name
- Dental ultrasonic surgical system handpiece FDA UDI
- Device Name
- Handpiece for Proxeo ULTRA FDA UDI
- Model / Reference
- 30327000 FDA UDI
- Description
- Handpiece for Proxeo ULTRA FDA UDI
Identifiers
- Primary DI / UDI-DI
- J021303270001 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Dental ultrasonic surgical system handpiece FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 FDA UDI
- Commercial Distribution
- Not 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
No
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
Moist Heat or Steam Sterilization FDA UDI
Proxeo ULTRA Handpiece PB-5 L Q by W & H Dentalwerk Bürmoos GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- W & H Dentalwerk Bürmoos GmbH
Sources (1)
- FDA UDI 25025804-bc60-49ca-95ba-58d323df294b 34 fields · synced Jun 8, 2026