VarioSurg 4 (120v)
VarioSurg 4 is an ultrasonic dental surgical system for oral bone cutting, scaling and root planing, and retrograde root-canal preparation. The 120 V system powers a compatible ultrasonic…
VarioSurg 4 is an ultrasonic dental surgical system for oral bone cutting, scaling and root planing, and retrograde root-canal preparation. The 120 V system powers a compatible ultrasonic handpiece and controls its operating functions.
A piezoelectric transducer in the handpiece converts the generator’s electrical signal into mechanical vibration at the attached tip. The control unit sets power, irrigation flow and operating mode, while the foot control supports irrigation adjustment, programme selection and ultrasound activation.
Reprocessing
The system is supplied non-sterile. Reusable handpieces and tips must be cleaned and sterilised at the medical facility before use. The handpiece includes LED illumination.
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 | Nakanishi Inc., Japan |
|---|---|
| FDA product code | DZI |
| Device type | Drill, Bone, Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 872.4120 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K254163 |
| Record published | 2026-04-23 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VarioSurg 4 (120V) | 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 |
| Woodpecker | Guilin Woodpecker Medical Instrument Co., Ltd. | 28 |
| VarioSurg | Nakanishi Inc. | 22 |
| Nobel Biocare® | Nobel Biocare AB | 20 |
Showing 12 of 265. All products under Drill, Bone, Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K254163 | 2025-12-23 |
| K073678 | 2008-07-10 |
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.