Ultrasonic Surgical Series
Basic Information
- Primary DI
- 08809260471986
- Basic UDI-DI Code
- B-08809260471986
- Reference
- SP-100
- Device Types
-
Sterilization
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- SAESHIN PRECISION CO.,LTD.
Additional Description
SP-100 is an ultrasonic tip among the components of SUS10. SUS10 combines the function of piezo surgery by using ultrasonic mechanical vibration and the function of dental implant motor surgery into one device. SUS10 consists of Control Box (main unit), Motor, Handpiece for implant surgery, Ultrasonic Handpiece for piezo surgery, Foot Controller, Ultrasonic tips and accessories. When the AC power is connected to the control box by the power cord, the control box has a program for ultrasonic surgery mode which be able to select options such as power (output intensity) and boost (vibration frequency), and for implant motor surgery mode which be able to select options such as speed, torque and gear ratio, and includes the memory function for input and output settings.
CND Nomenclature Codes
| Code | Description |
|---|---|
| L1899 | ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | KR19/81826253 | SGS Belgium NV | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).