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Singapore HSA registration DE0503819

Sirona SiroSonic Scaler

Singapore flagSingapore·CLASS B·Sirona Dental Systems GmbH·Registered November 15, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration information
Registration Number
DE0503819
Registration Date
November 15, 2019
Retention Due Date
November 14, 2025
Product description
SiroSonic L / TL is used to treat dental disease. The treatment is for the following uses: • Supragingival removal of plaque and tartar (scaling) • Subgingival removal of plaque and calculus (periodontology) • Cleaning implants as well as metallic and ceramic restorations (implant cleaning tip) • Irrigation of prepared root canals (endo) • Liquefying of thixotropic composites (CEM) • Micropreparation • Retrograde root treatment (endo).
Product Owner
Name
Sirona Dental Systems GmbH
Short Name
Sirona Dental Systems GmbH
Address
Fabrikstrasse 31, 64625 Bensheim, GERMANY
Registrant
Name
DENTSPLY SIRONA SINGAPORE PTE LTD
Address
1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Importer
Name
DENTSPLY SIRONA SINGAPORE PTE LTD
Address
1 WALLICH STREET, GUOCO TOWER, #18-02, SINGAPORE 078881
Model information
Model Name(s)
CEM-Set Nr 6L Contact cap Instrument No. 3L Instrument No. 4L SiroRetro KL SiroRetro KR SiroRetro GL SiroRetro GR SIRORETRO-SET SiroPrep M1 SiroSonic L SiroPrep D1 SiroPrep M2 SiroPrep D2 SIROPERIO-Set: SIROPERIO 1-3 SIROPREP-SET Spray adapter L SiroPerio 1 SiroPerio 2 SiroPerio 3 Spray adapter PerioSonic SiroPerio 4 PS SiroSonic TL SiroImplant IP1 SiroPerio PE 5 SiroPerio PE 6 Insert IP1 Set Instrument No. 3L (2pcs) Set Instrument No. 4L (2pcs) Set Instrument No. 3L (6pcs) Set Instrument No. 4L (6pcs) Set SiroSonic L Set SiroSonic TL Instrument No. 1L Instrument No. 2L
Model Identifier(s)
1894307 1894372 1894455 1894463 5457887 5457895 5457903 5457911 5457929 5904276 5913509 5947309 5947358 5947366 5950246 5950253 6002286 6044825 6044833 6044841 6141852 6177005 6212216 6343052 6343078 6343086 6343094 6412451 6412469 6541044 6541051 6562834 6562842 8924250 8924268
About this record

Access comprehensive regulatory information for Sirona SiroSonic Scaler in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503819 and owned by Sirona Dental Systems GmbH. The device was registered on November 15, 2019.

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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