Identity
- Trade Name
- Piezo Controller PC-1.0 FDA UDI
- Generic Name
- Dental ultrasonic surgical system generator FDA UDI
- Device Name
- Piezo Controller for Proxeo ULTRA Built-in FDA UDI
- Model / Reference
- 30294000 FDA UDI
- Description
- Piezo Controller for Proxeo ULTRA Built-in FDA UDI
Identifiers
- Primary DI / UDI-DI
- J021302940001 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Dental ultrasonic surgical system generator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4850 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 ultrasonic surgical system generator
Piezo Controller PC-1.0 by W & H Dentalwerk Bürmoos GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental ultrasonic surgical system generator.
- BenTips Piezosurgery Unit — BENNETT JACOBY, DDS, MS, INC. · Class II
- OSADA ENAC OE-F15 — OSADA ELECTRIC CO., LTD. · Class II
- OSADA ENAC OEW-10 — OSADA ELECTRIC CO., LTD. · Class II
- VarioSurg — NAKANISHI INC. · Class II
- OSADA ENAC OE-505 — OSADA ELECTRIC CO., LTD. · Class II
- Proxeo ULTRA PB-520 — W & H Dentalwerk Bürmoos GmbH · Class II
- Supply Hose VP-5 — W & H Dentalwerk Bürmoos GmbH · Class II
- Proxeo ULTRA PB-510 — W & H Dentalwerk Bürmoos GmbH · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- W & H Dentalwerk Bürmoos GmbH
Sources (1)
- FDA UDI 9d7ae968-9dfa-4b43-b0ab-d546d57a9fc2 33 fields · synced Jun 8, 2026