Identity
- Trade Name
- ProUltra PiezoFlow FDA UDI
- Generic Name
- Dental torque wrench FDA UDI
- Device Name
- ProUltra PiezoFlow SOLO FDA UDI
- Model / Reference
- PIEZOFLOWSOLO FDA UDI
- Description
- ProUltra PiezoFlow SOLO FDA UDI
Identifiers
- Catalog Number
- PIEZOFLOWSOLO FDA UDI
- Primary DI / UDI-DI
- D716PIEZOFLOWSOLO1 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Dental torque wrench 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental torque wrench
ProUltra PiezoFlow by Tulsa Dental Products Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Azure — TERRATS MEDICAL SL. · Class I
- Graduated Torque Wrench — Sterngold Dental LLC · Class I
- SURGICAL TORQUE RATCHET — S.I.N. - Sistema DE Implante Nacional S.A. · Class I
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
- Tulsa Dental Products Llc
Sources (1)
- FDA UDI a8616ded-6054-4ef2-b3b2-97dafa1f4bf8 34 fields · synced Jun 1, 2026