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Gebr. Brasseler SonicLine Scaler Tip - HSA Registration DE0507943

Access comprehensive regulatory information for Gebr. Brasseler SonicLine Scaler Tip in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507943 and owned by Gebr. Brasseler GmbH & Co.KG. The device was registered on March 24, 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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CLASS B
DE0507943
Gebr. Brasseler SonicLine Scaler Tip
HSA Registration Number: DE0507943
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Product Description

The sonic instruments are intended for the mechanical removal of plaque, tartar and concrements. They can also be used depending on their intended application for the mechanical removal of deposits and concrements from dental and root surfaces in the region of deep gingival pockets as part of periodontopathy treatments. Sonic rinsing tip is used for sound-based activation of rinsing and disinfecting solutions previously inserted into the root canal and for removing bacterial biofilms. The vibration induced in the instrument tip is transferred to the liquid in the root canal, causing the current hereby generated to remove the smear layer. In addition, this enables the rinsing liquid to penetrate even the tiniest of cavities (e.g. dentinal tubules), thus ensuring an effective disinfection of the root canal.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0507943
Registration Date
March 24, 2023
Retention Due Date
March 23, 2026
Product Owner
Short Name
Gebr. Brasseler GmbH & Co.KG
Address
Trophagener Weg 25, 32657 Lemgo, Postfach 160-32631 Lemgo, GERMANY
Registrant
Address
57 UBI AVENUE 1, UBI CENTRE, #04-01, SINGAPORE 408936
Importer
Address
57 UBI AVENUE 1, UBI CENTRE, #04-01, SINGAPORE 408936
Model Information
Model Name(s)
Clamping nut for tip holder SF1981 SonicLine SonicLine SonicLine SonicLine SonicLine SonicLine SonicLine SonicLine SonicLine SonicLine SonicLine SonicLine SonicLine Endo rinsing tip made of NiTi-TiN SonicLine
Model Identifier(s)
587 000 SF1 000 SF10L 000 SF10R 000 SF10T 000 SF11 000 SF1981 000 SF1982 000 SF2 000 SF3 000 SF4 000 SF4L 000 SF4R 000 SF6 000 SF65 000 020 SF8 000