AIR-Flow
PERIOFLOW Application with PI instrument
1manufacturer
21catalogue numbers in this listing
Who Else Makes It
Registered in Guangxi.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
Record
| Listed by | E.M.S. Electro Medical Systems S.A., Switzerland |
|---|---|
| FDA product code | KOJ |
| Device type | Airbrush |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6080 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K190124 |
| Record published | 2019-11-11 |
| Record revised | 2026-07-03 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FS-466HF | In distribution | |
| FS-466HF | In distribution | |
| FS-467HF | In distribution | |
| FS-474 | In distribution | |
| FT-230-2B-V02 | In distribution | |
| FT-230/A | In distribution | |
| FS-444 | In distribution | |
| FS-457 | In distribution | |
| FT-230W/A | In distribution | |
| FS-465 | In distribution | |
| FS-474 | In distribution | |
| FS-457HF | In distribution | |
| FS-466 | In distribution | |
| FS-474 | In distribution | |
| FT-230S-STM2 | In distribution | |
| FT-230-2B-V02 | In distribution | |
| FS-467HF | In distribution | |
| FS-465HF | In distribution | |
| FS-447 | In distribution | |
| FT-230HF-0B-302 | In distribution | |
| FS-465 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Etchmaster | Reliance Orthodontic Products, Inc. | 21 |
| Etchmaster | Groman Inc. | 18 |
| Johnson-Promident | Young Innovations Inc. | 11 |
| Jetpolisher 2000 | Deldent, Ltd. | 10 |
| HuFriedyGroup | HU-Friedy MFG Co., LLC | 8 |
| Microetcher | Danville Materials, LLC | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| AIR-Flow-Piezon | E.M.S. Electro Medical Systems S.A. | 5 |
| PWR Handpiece | HU-Friedy MFG Co., LLC | 3 |
| CoJet™ Prep | 3M Deutschland GmbH | 2 |
| JP/JST/JS Handpiece | Deldent, Ltd. | 2 |
| GBT Machine Wireless Pedal | E.M.S. Electro Medical Systems S.A. | 2 |
Showing 12 of 48. All products under Airbrush
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| E.M.S. Electro Medical Systems S.A. | UDI-DI | 2024-03-13 | Class II | Process control | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles). | 342 |
| E.M.S. Electro Medical Systems S.A. | UDI-DI | 2024-03-13 | Class II | Process control | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles). | 462 |
| E.M.S. Electro Medical Systems S.A. | UDI-DI | 2024-03-13 | Class II | Process control | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles). | 54 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.