Identity
- Trade Name
- Cavitron® FDA UDI
- Generic Name
- Dental abrasive air jet system FDA UDI
- Device Name
- Cavitron® prophy-jet® Air Polishing Prophylaxis System with Tap-On™ Technology and Cavitron® JET-Mate™ Handpiece with Swivel. Also contains: Air Polishing Insert, and 13 oz. Prophy Powder Bottle. 115V FDA UDI
- Model / Reference
- 8195001 FDA UDI
- Description
- Cavitron® prophy-jet® Air Polishing Prophylaxis System with Tap-On™ Technology and Cavitron® JET-Mate™ Handpiece with Swivel. Also contains: Air Polishing Insert, and 13 oz. Prophy Powder Bottle. 115V FDA UDI
Identifiers
- Primary DI / UDI-DI
- D00381950011 FDA UDI
- FDA Product Code
- ELC FDA UDI
- GMDN Term
- Dental abrasive air jet system 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
Yes
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental abrasive air jet system
Cavitron® by Dentsply Professional — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental abrasive air jet system.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class I
- AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class I
- AIR-FLOW-PIEZON — E.M.S. Electro Medical Systems S.A. · Class II
- AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class II
- AIR-FLOW — E.M.S. Electro Medical Systems S.A. · Class I
- AIR-FLOW-PIEZON — E.M.S. Electro Medical Systems S.A. · Class II
- JETPOLISHER 2000 — DELDENT LTD. · Class II
- AIR-FLOW-PIEZON — 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
- Dentsply Professional
Sources (1)
- FDA UDI b9192353-2d45-4290-90ae-332b19ff72a2 35 fields · synced May 30, 2026