Identity
- Trade Name
- AIR-FLOW FDA UDI
- Generic Name
- Dental abrasive air jet system FDA UDI
- Device Name
- AIR-FLOW Handpiece 120° FDA UDI
- Model / Reference
- EL-308#YC/001 FDA UDI
- Description
- AIR-FLOW Handpiece 120° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07613353207045 FDA UDI
- 510(k) Number
- K110173 FDA UDI
- FDA Product Code
- EFB FDA UDI
- GMDN Term
- Dental abrasive air jet system 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
Yes
FDA UDI
Serial Number
No
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
Air-Flow by E.M.S. Electro Medical Systems S.A. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental abrasive air jet system.
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- Etchmaster — GROMAN INC. · Class II
- MICROETCHER — DANVILLE MATERIALS, LLC · Class II
- Henry Schein — HENRY SCHEIN, INC. · Class II
- MB Quick coupling Sirona — DELDENT LTD. · Class II
- Etchmaster — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class II
- Etchmaster — GROMAN INC. · Class II
Cleared under the same submission
K110173 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 d74aef58-a303-4d9a-8675-daaf47d7a7d5 35 fields · synced May 31, 2026