AIR-Flow
AIRFLOW MAX Introduction Kit
14manufacturers in China registered for this device type
15catalogue numbers in this listing
10510(k) clearances naming this product code
3recalls on this code
Who Else Makes It
Concentrated in Guangdong (4), Guangxi (4), Shandong (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| China Zhong YAN Chang Xing International Co., Ltd. | Zibo | Shandong | Contract manufacturer | 5 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Wenzhou Baiyu Glasses Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 10 |
| Shenzhen Ainengke Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guilin Refine Medical Instrument Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 7 |
| Shenzhen Micro Electric Intelligence Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
| Changzhou Bomedent Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Nanning Baolai Medical Instrument Co., Ltd. | Nanning | Guangxi | Manufacturer | 4 |
Showing 12 of 14. All 14 manufacturers in China registered for Scaler, Ultrasonic
Record
| Listed by | E.M.S. Electro Medical Systems S.A., Switzerland |
|---|---|
| FDA product code | ELC |
| Device type | Scaler, Ultrasonic |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4850 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K900709 |
| Record published | 2016-09-01 |
| 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 |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2017-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| a | In distribution | |
| B | In distribution | |
| B | In distribution | |
| FT-230-2B-302 | In distribution | |
| FT-230-0B-302 | In distribution | |
| a | In distribution | |
| a | In distribution | |
| C | In distribution | |
| FS-477/US | In distribution | |
| FS-477/US | In distribution | |
| FT-230-2B-302 | In distribution | |
| c | In distribution | |
| FS-477/US | In distribution | |
| C | In distribution | |
| b | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 501 |
| Piezon | E.M.S. Electro Medical Systems S.A. | 245 |
| Acteon | Satelec | 236 |
| Mectron | Mectron SPA | 209 |
| Varios | Nakanishi Inc. | 158 |
| BioSonic | Coltene/Whaledent Gmbh & Co. KG | 142 |
| Cavitron® | Dentsply Professional | 137 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 113 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 83 |
| Obtura Spartan | Obtura Spartan Endodontics | 74 |
| Henry Schein | Henry Schein, Inc. | 48 |
| Baolai | Nanning Baolai Medical Instrument Co., Ltd. | 46 |
Showing 12 of 653. All products under Scaler, Ultrasonic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253254 | 2026-01-28 |
| K190124 | 2019-10-20 |
| K191079 | 2019-08-16 |
| K140990 | 2015-02-27 |
| K132445 | 2013-12-06 |
| K132443 | 2013-11-22 |
| K110173 | 2011-04-07 |
| K093723 | 2010-09-08 |
| K093000 | 2010-07-30 |
| K050710 | 2005-03-30 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| E.M.S. Electro Medical Systems S.A. | 510(k) number | 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. | 510(k) number | 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. | 510(k) number | 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.