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Nakanishi FX dental handpiece - HSA Registration DE0506294

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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CLASS B
DE0506294
Nakanishi FX dental handpiece
HSA Registration Number: DE0506294
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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)”

Device 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 Owner
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