Dental High-Speed Turbine Handpiece
This high speed turbine handpiece is a dental instrument for removing decay or excess filling material, preparing cavities and crowns, finishing restorations, root canal preparation and…
This high speed turbine handpiece is a dental instrument for removing decay or excess filling material, preparing cavities and crowns, finishing restorations, root canal preparation and tooth polishing. It is intended for professional dental use.
The device combines a handpiece and connector, with an angled head and a textured grip for handling. Its cartridge provides the rotating cutting or finishing action used during the selected dental procedure.
Listed Item
The Dental High-speed Turbine Handpiece is the dental clinic, hospital treatment for patients with tooth disease tools, which is an effective instrument for drilling, grinding, repairing. It composed of handpiece and a connector. The handle is slide-proof, comfortable and easy to clean. Handpiece and adaptors can bear steam disinfection at 135°C. The head angle can provide better operational vision and angle so that work efficiency can be improved. Cartridges have high precision when rotating; cartridges have low noise and high efficiency. The scope of application: for dental professional use only. Lubricant should be used during routine maintenance (e.g. after each patient use and prior to sterilization). In order to avoid the risk, user must buy and use specified lubricant type “PANA SPRAY Plus” manufactured by NAKANISHI INC (cleared in K163483).
Maintenance and Reprocessing
The handpiece and adapters tolerate steam reprocessing at 135 degrees Celsius. Routine maintenance requires the specified PANA SPRAY Plus lubricant after patient use and before sterilization. Cleaning, lubrication and sterilization form part of preparation for subsequent use.
Who Else Makes It
Concentrated in Guangdong (7), Guangxi (1), Shaanxi (1).
| 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 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Guangdong Jinme Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 13 |
| Sinol Dental Limited | Xianyang | Shaanxi | Manufacturer | 5 |
| Foshan Soco Precision Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 4 |
| Shanghai Dental Instrument Factory Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Foshan Topmed Dental Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Foshan Wenjian Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Litu Tech Ltd. | Zhongshan | Guangdong | Manufacturer | 1 |
Record
| Listed by | Guangdong Jinme Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | EFB |
| Device type | Handpiece, Air-Powered, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| Establishment | Manufacturer |
| 510(k) | K170229 |
| Record published | 2025-07-15 |
| Record revised | 2018-11-22 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| T | In distribution | |
| TUP | In distribution | |
| S | In distribution | |
| SUP | In distribution | |
| TUQP | In distribution | |
| SP | In distribution | |
| SUQP | In distribution | |
| TU | In distribution | |
| SUQ | In distribution | |
| TP | In distribution | |
| SU | In distribution | |
| TUQ | In distribution | |
| T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SUQP | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AIR-Flow | E.M.S. Electro Medical Systems S.A. | 220 |
| Lares Research | Lares Research | 130 |
| MK-dent | MK-dent GmbH | 129 |
| Vector R&D, Inc | Vector R&D, Inc. | 114 |
| MK-dent Germany® | MK-dent GmbH | 112 |
| Johnson-Promident | Young Innovations Inc. | 92 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 76 |
| Airlight | Beyes Dental Canada, Inc. | 65 |
| Henry Schein | Henry Schein, Inc. | 62 |
| MicroP Dental | Microp Technology (Taiwan), Inc. | 51 |
| StarDental Instrument Solutions | Dentalez, Inc. | 47 |
| Air-Driven Dental Handpieces | MDK Co., Ltd. | 39 |
Showing 12 of 968. All products under Handpiece, Air-Powered, Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240337 | 2024-11-13 |
| K170236 | 2017-11-21 |
| K170229 | 2017-11-08 |
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.