Wireless Footctrl + Dongle
Used to controle the console used in dentistry for implantology, dental surgery and endodontic work.
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Foshan Coxo Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 19 |
| Guangxi Ehall Medical Technology Co., Ltd. | Nanning | Guangxi | Manufacturer | 17 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
Record
| Listed by | Bien-AIR Dental SA, Switzerland |
|---|---|
| FDA product code | EBW |
| Device type | Controller, Foot, Handpiece And Cord |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Record published | 2025-02-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1601192-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| A-dec | A-dec, Inc. | 43 |
| X-Cube | Saeshin Precision Co., Ltd. | 22 |
| Maxso | Beyes Dental Canada, Inc. | 20 |
| NLZ | Nakanishi Inc. | 16 |
| Surgic Pro | Nakanishi Inc. | 15 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 13 |
| DTE | Guilin Woodpecker Medical Instrument Co., Ltd. | 11 |
| woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 10 |
| NL400 | Nakanishi Inc. | 9 |
| NLX | Nakanishi Inc. | 9 |
| Surgic XT Plus | Nakanishi Inc. | 6 |
| Axiom® | Etablissements Anthogyr | 6 |
Showing 12 of 256. All products under Controller, Foot, Handpiece And Cord
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K092214 | 2009-12-15 |
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.