Dentsply Sirona Orthodontics SpaceFile Interproximal Reduction Files - HSA Registration DE0508412
Access comprehensive regulatory information for Dentsply Sirona Orthodontics SpaceFile Interproximal Reduction Files in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508412 and owned by Dentsply Sirona Orthodontics Inc.. The device was registered on August 18, 2023.
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.
Interproximal reduction (IPR) is a technique used during orthodontic treatment to create space for tooth alignment. The SpaceFile® and SpaceFile Grip accessory are devices intended to assist clinicians in manual “Interproximal Reduction” (IPR) procedures, which includes interdental enamel reduction, slenderizing, stripping, selective enamel reduction and enamel re- proximation procedures.