VarioSurg 4 W/o FC (120v)
VarioSurg 4 is an ultrasonic dental surgical system for bone cutting in oral surgery, scaling and root planing, and retrograde root canal preparation. This 120-volt configuration is…
VarioSurg 4 is an ultrasonic dental surgical system for bone cutting in oral surgery, scaling and root planing, and retrograde root canal preparation. This 120-volt configuration is supplied without a foot control. A compatible handpiece drives the working tip at an ultrasonic frequency.
The control unit produces an electrical signal that a piezoelectric transducer in the handpiece converts into mechanical vibration. The clinician adjusts ultrasonic output and irrigation flow at the unit. The handpiece also provides LED illumination.
Controls and Reuse
A compatible wireless foot control can operate irrigation, program selection and ultrasound activation. The system can connect to Surgic Pro2 so one foot control operates both. The handpiece and tips are supplied nonsterile and require cleaning and sterilization before repeated use.
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 w/o FC (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.