HSA · registration DE0506294Nakanishi FX dental handpiece
- Registration number
- DE0506294
- Model name
- FX Series FX25; FX Series FX15; FX Series FX57; FX Series FX75; FX Series FX23; FX Series FX22; FX Series FX65
- Model identifier
- C1052002; C1053002; C1054002; C1055002; C1056002; C1129; H1014002
- Registration date
- October 15, 2021
- Source update date
- April 01, 2022
- Risk class
- Class B
- Product owner
- Nakanishi Inc.
- Registrant / registration holder
- NYPRAX PHARMA PTE. LTD.
• FX25, FX23, FX22, FX15: This medical device is intended for transmitting rotation of the power source at the direct drive ratio or at a different gear ratio, thereby running the instrument such as a bur or a reamer to cut and polish natural or artificial teeth during dental treatment • FX75: This medical device is intended for transmitting rotation of the power source at a reduction gear ratio, thereby running the rotary endodontic instrument, etc. to perform endodontic treatments such as root canal enlargement. • FX57: This handpiece is designed only for clinical dental use (Polishing) by qualified personnel. • FX65: For Dental Treatment / Dental Prosthetics (Cutting, Polishing)”
- Product owner address
- 700 Shimohinata, Kanuma, Tochigi, 322-8666, Japan
- Registrant address
- 59 UBI AVENUE 1, #07-14, Singapore 408938
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.