Dental High-speed Turbine Handpiece
- Primary DI
- 06971119540012
- Brand
- Dental High-speed Turbine Handpiece
- Company
- Guangdong JINME Medical Technology Co., Ltd.
- Model
- T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SU
- Device description
- 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).
- Published
- 2018-01-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Sterile
- true
Product Codes#
| Code | Name |
|---|---|
| EFB | Handpiece, Air-Powered, Dental |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| EFB | Handpiece, Air-Powered, Dental | Dental | 1 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K170229 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 06971119540012 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 06971119540012 | 06971119540012 | 6971119540012 |
GMDN Terms#
| Term | Definition |
|---|---|
| Dental power tool system handpiece, pneumatic | A hand-held dental device that includes a chuck for attaching a rotary dental endpiece (e.g., drill bits, burs, reamers) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. The device incorporates a small turbine motor normally driven by compressed air, and which typically has a built-in water spray for cooling the rotating device; the endpiece(s) are not included. The handpiece is typically connected through the dental delivery system or a freestanding independent system. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 543260808
- Device count
- 1
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- true
- Sterilization required before use
- true
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| 06971119540180 | Dental High-Speed Turbine Handpiece | TUP | 2025-07-15 | |
| 06971119540197 | Dental High-Speed Turbine Handpiece | SP | 2025-07-15 | |
| 06971119540203 | Dental High-Speed Turbine Handpiece | TP | 2025-07-15 | |
| 06971119540227 | Dental High-Speed Turbine Handpiece | SU | 2025-07-15 | |
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