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Kerr Endodontics ZenFlex™ Gutta Percha Points - HSA Registration DE0510509

Access comprehensive regulatory information for Kerr Endodontics ZenFlex™ Gutta Percha Points in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510509 and owned by Kerr Italia S.r.l.. The device was registered on March 26, 2025.

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
DE0510509
Kerr Endodontics ZenFlex™ Gutta Percha Points
HSA Registration Number: DE0510509
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Product Description

Intended Use: ZenFlex Gutta Percha Points are used to obturate the root canal as part of an endodontic treatment procedure. Indication For Use: Gutta-percha points are utilized to fill (obturate) an open root canal during root canal treatment.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0510509
Registration Date
March 26, 2025
Retention Due Date
March 25, 2026
Product Owner
Short Name
Kerr Italia S.r.l.
Address
Via Passanti, 174, Scafati(SA), 84018, ITALY
Registrant
Address
7500A BEACH ROAD, THE PLAZA, #09-308, SINGAPORE 199591
Importer
Address
13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905 13 STAMFORD ROAD, CAPITOL PIAZZA, #02-11, SINGAPORE 178905
Model Information
Model Name(s)
ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points ZenFlex Gutta Percha Points
Model Identifier(s)
825-9800 825-9820 825-9825 825-9830 825-9835 825-9840 825-9845 825-9900 825-9920 825-9925 825-9930 825-9935 825-9940 825-9945