Identity
- Trade Name
- AIR-FLOW FDA UDI
- Generic Name
- Dental abrasive air jet system handpiece FDA UDI
- Device Name
- AIR-FLOW® handy 2+ Orange - Connector Sirona FDA UDI
- Model / Reference
- FT-170#G/055 FDA UDI
- Description
- AIR-FLOW® handy 2+ Orange - Connector Sirona FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07613353181468 FDA UDI
- 510(k) Number
- K022119 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental abrasive air jet system handpiece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4200 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
Moist Heat or Steam Sterilization FDA UDI
Category: Dental abrasive air jet system handpiece
Air-Flow by E.M.S. Electro Medical Systems S.A. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental abrasive air jet system handpiece.
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Cleared under the same submission
K022119 also covers:
- AIR-FLOW — E.M.S. Electro Medical Systems S.A.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A.
- AIR-FLOW — E.M.S. Electro Medical Systems S.A.
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 I | Pending data |
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Manufacturer
- Manufacturer
- E.M.S. Electro Medical Systems S.A.
Sources (1)
- FDA UDI c70822d5-a616-406e-81fb-722a783965af 35 fields · synced May 30, 2026