Woodpecker
Ultrasonic dental scaling/debridement system handpiece tip, endodontic
2manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangxi (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Guilin Woodpecker Medical Instrument Co., Ltd., China |
|---|---|
| FDA product code | DZI |
| Device type | Drill, Bone, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4120 |
| Establishment | Manufacturer |
| 510(k) | K111290 |
| Record published | 2017-11-23 |
| Record revised | 2019-02-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| US20 | In distribution | |
| Surgic Touch | In distribution | |
| ULTRASURGERY LED | In distribution | |
| UL8 | In distribution | |
| US-II LED | In distribution | |
| SS2 | In distribution | |
| P1 | In distribution | |
| US18 | In distribution | |
| ULTRASURGERY | In distribution | |
| UI3 | In distribution | |
| UC6 | In distribution | |
| US-II | In distribution | |
| US15 | In distribution | |
| US-II套装 | In distribution | |
| US-II | In distribution | |
| SS8 | In distribution | |
| US-II套装 | In distribution | |
| US21 | In distribution | |
| ULTRASURGERY | In distribution | |
| US13 | In distribution | |
| US-II LED | In distribution | |
| UC4 | In distribution | |
| SS1 | In distribution | |
| SS5 | In distribution | |
| UC5 | In distribution | |
| Ultrasurgery LED | In distribution | |
| US25 | In distribution | |
| Surgic Touch LED | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Drill, Bone, Powered | Synthes Gmbh | 150 |
| Acteon | Satelec | 87 |
| Neoss Implant System | Neoss AB | 74 |
| Mectron | Mectron SPA | 48 |
| OneDrill Surgical Drill | Osseofuse International Inc. | 48 |
| Silfradent srl | Silfradent SRL | 45 |
| MatrixMANDIBLE | Synthes Gmbh | 31 |
| DIRECTguide™ Step Drill | Implant Direct Sybron Manufacturing LLC | 31 |
| DIRECTguide™ Guided Step Drill | Implant Direct Sybron Manufacturing LLC | 30 |
| VarioSurg | Nakanishi Inc. | 22 |
| Nobel Biocare® | Nobel Biocare AB | 20 |
| Drill, Bone, Powered | Synthes (U.S.A.) LP | 19 |
Showing 12 of 265. All products under Drill, Bone, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111290 | 2011-11-18 |
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.