Pure Global
Singapore HSA registration DE0502906

Ivoclar Apexit Plus/ ApexCal pack

Singapore flagSingapore·CLASS B·Ivoclar Vivadent AG·Registered March 20, 2019
Device classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration information
Registration Number
DE0502906
Registration Date
March 20, 2019
Change Notification Approval Date
March 01, 2022
Retention Due Date
March 19, 2026
Product description
Apexit Plus is indicated for – Permanent obturation following vital pulp extirpation – Permanent obturation following the removal of a gangrenous pulp and placement of intracanal disinfectant dressings – Permanent obturation in cases with external and internal root resorption. ApexCal is indicated for – Temporary disinfectant dressing, applied during endodontic therapy – Indirect pulp capping or management of deep caries lesions – Direct pulp capping
Product Owner
Name
Ivoclar Vivadent AG
Short Name
Ivoclar Vivadent AG
Address
Bendererstrasse 2, 9494 Schaan, LIECHTENSTEIN
Registrant
Name
SONAX BUSINESS SOLUTIONS
Address
100 PECK SEAH STREET, PS100, #08-14, SINGAPORE 079333
Importer
Name
GOLDPLUS UNIVERSAL PTE LTD
Address
103 KALLANG AVENUE, AIS INDUSTRIAL BUILDING, #06-02, SINGAPORE 339504
Model information
Model Name(s)
Apexit Plus Refill Apexit Plus Refill Apexit Plus/ApexCal Promo Pack
Model Identifier(s)
593991 595377 598960
About this record

Access comprehensive regulatory information for Ivoclar Apexit Plus/ ApexCal pack in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502906 and owned by Ivoclar Vivadent AG. The device was registered on March 20, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B