Identity
- Trade Name
- SA-320 Piezomed 1.8m BTI FDA UDI
- Generic Name
- Dental ultrasonic surgical system handpiece tip FDA UDI
- Model / Reference
- 30078003 FDA UDI
Identifiers
- Primary DI / UDI-DI
- J021300780031 FDA UDI
- FDA Product Code
- DZI FDA UDI
- GMDN Term
- Dental ultrasonic surgical system handpiece tip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.4120 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
No
FDA UDI
Category: Dental ultrasonic surgical system handpiece tip
SA-320 Piezomed 1.8m BTI by W & H Dentalwerk Bürmoos GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental ultrasonic surgical system handpiece tip.
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- PIEZON MASTER SURGERY — E.M.S. Electro Medical Systems S.A. · 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 |
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Manufacturer
- Manufacturer
- W & H Dentalwerk Bürmoos GmbH
Sources (1)
- FDA UDI 2afaee71-4014-4c37-a95b-138c5c1d04b7 32 fields · synced Jun 1, 2026