Singapore HSA registration DE0506294
Nakanishi FX dental handpiece
Singapore·CLASS B·Nakanishi Inc.·Registered October 15, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0506294
- Registration Date
- October 15, 2021
- Change Notification Approval Date
- April 01, 2022
- Retention Due Date
- October 14, 2025
Product description
• 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
- Name
- Nakanishi Inc.
- Short Name
- Nakanishi Inc.
- Address
- 700 Shimohinata, Kanuma, Tochigi, 322-8666, JAPAN
Registrant
- Address
- 116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Importer
- Address
- 57 UBI AVENUE 1, UBI CENTRE, #04-01, SINGAPORE 408936 2 CLEMENTI LOOP, LOGIS HUB @ CLEMENTI, #01-01, SINGAPORE 129809
Model information
- Model Name(s)
- FX Series FX25 FX Series FX15 FX Series FX57 FX Series FX75 FX Series FX23 FX Series FX22 FX Series FX65
- Model Identifier(s)
- C1052002 C1053002 C1054002 C1055002 C1056002 C1129 H1014002
About this record
Access comprehensive regulatory information for Nakanishi FX dental handpiece in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506294 and owned by Nakanishi Inc.. The device was registered on October 15, 2021.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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