Woodpecker
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery…
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
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 | Guilin Woodpecker Medical Instrument Co., Ltd., China |
|---|---|
| FDA product code | EBW |
| Device type | Controller, Foot, Handpiece And Cord |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Manufacturer |
| 510(k) | K211358 |
| Record published | 2024-10-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Implant Smart | In distribution | |
| Implant NX | In distribution | |
| ES5 Pro | In distribution | |
| ES5 Pro+ | In distribution | |
| ES5+ | In distribution | |
| ES5 | In distribution | |
| Implanter LED | In distribution | |
| Implant Air | In distribution | |
| Implanter | In distribution | |
| Implant Pilot | 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 |
| NL400 | Nakanishi Inc. | 9 |
| NLX | Nakanishi Inc. | 9 |
| Surgic XT Plus | Nakanishi Inc. | 6 |
| Axiom® | Etablissements Anthogyr | 6 |
| StarDental Instrument Solutions | Dentalez, Inc. | 5 |
Showing 12 of 256. All products under Controller, Foot, Handpiece And Cord
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211358 | 2022-11-21 |
| K203706 | 2022-01-13 |
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.