Singapore HSA registration DE0508412
Dentsply Sirona Orthodontics SpaceFile Interproximal Reduction Files
Singapore·CLASS B·Dentsply Sirona Orthodontics Inc.·Registered August 18, 2023Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0508412
- Registration Date
- August 18, 2023
- Change Notification Approval Date
- October 04, 2024
- Retention Due Date
- August 17, 2025
Product description
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.
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)
- SpaceFile®IPR Strips-Double Sided Assorted PK9 SpaceFile®IPR Strips-Left Sided Assorted PK9 SpaceFile®IPR Strips-Right Sided Assorted PK9 SpaceFile®IPR Strips-Dbl Sided-Medium/Blue PK8 SpaceFile®IPR Strips-Dbl Sided-X Coarse Black PK8 SpaceFile®IPR Coping Saw /Gold (Brown) PK8 SpaceFile®IPR Strips-Dbl Sided-Polishing/Gray PK8 SpaceFile®IPR Strips-Dbl Sided-Coarse/Green PK8 SpaceFile® IPR Strips-Left Sided-Medium/Blue PK8 SpaceFile®IPR Strips-Left Sided-X-Coarse/Black PK8 SpaceFile®IPR Strips-Left Sided-Polishing/Gray PK8 SpaceFile®IPR Strips-Left Sided-Coarse/Green PK8 SpaceFile®IPR Strips-L Sided-Finishing/Purple PK8 SpaceFile®IPR Strips-Left Sided-Fine/Red PK8 SpaceFile®IPR Strips-Left Sided-XX Fine/White PK8 SpaceFile®IPR Strips-Left Sided-X Fine/Yellow PK8 SpaceFile® IPR Strips-Dbl Sided-Finishing/Purple SpaceFile®IPR Strips-Double Sided-Fine/Red PK8 SpaceFile®IPR Strips-Right Sided-Medium/Blue PK8 SpaceFile®IPR Strips-Right Sided-X Coarse/Black PK8 SpaceFile®IPR Strips-Right Sided-Polishing/Gray PK8 SpaceFile®IPR Strips-Right Sided-Coarse/Green PK8 SpaceFile®IPR Strips-R Sided-Finishing/Purple PK8 SpaceFile®IPR Strips-Right Sided-Fine/Red PK8 SpaceFile®IPR Strips-Right Sided-XX Fine/White PK8 SpaceFile®IPR Strips-Right Sided-X Fine/Yellow PK8 SpaceFile®IPR Strips-Double Sided-XX Fine/White PK8 SpaceFile®IPR Strips-Double Sided-X Fine/Yellow PK8
- Model Identifier(s)
- 40034 40034-LS 40034-RS 40035-BL 40035-BLK 40035-CS 40035-G 40035-GR 40035-LS-BL 40035-LS-BLK 40035-LS-G 40035-LS-GR 40035-LS-P 40035-LS-R 40035-LS-W 40035-LS-Y 40035-P 40035-R 40035-RS-BL 40035-RS-BLK 40035-RS-G 40035-RS-GR 40035-RS-P 40035-RS-R 40035-RS-W 40035-RS-Y 40035-W 40035-Y
About this record
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.
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