Singapore HSA registration DE0508507
Dentsply Sirona Orthodontics SureSmile Aligner Starter Kit
Singapore·CLASS B·Dentsply Sirona Orthodontics Inc.·Registered September 22, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0508507
- Registration Date
- September 22, 2023
- Retention Due Date
- September 21, 2025
Product description
Interproximal reduction (IPR) is a technique used during orthodontic treatment to create space for tooth alignment. The IPR SpaceFile® and IPR SpaceFile® Grip are devices intended to assist clinicians in “Interproximal Reduction” (IPR) procedures, which includes interdental enamel reduction, slenderizing, stripping, selective enamel reduction and enamel reproximation procedures. SpaceFile® Strip can be connected to a Contra- angle Handpiece which in turn is connected to an Air-motor, facilitating the IPR process through vibrations, reducing friction between SpaceFile® Strip and patient tooth enamel, and increasing clinician’s precision and manipulation.
Product Owner
- Short Name
- Dentsply Sirona Orthodontics Inc.
- Address
- 7290 26th Court East, Sarasota FL 34243, UNITED STATES
Registrant
- Address
- 1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Importer
- Address
- 1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Model information
- Model Name(s)
- SureSmile Aligner Doctor Kit
- Model Identifier(s)
- ORX00006
About this record
Access comprehensive regulatory information for Dentsply Sirona Orthodontics SureSmile Aligner Starter Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508507 and owned by Dentsply Sirona Orthodontics Inc.. The device was registered on September 22, 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.
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