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Ivoclar Dental sealants, pit/fissure - HSA Registration DE0504300

Access comprehensive regulatory information for Ivoclar Dental sealants, pit/fissure in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504300 and owned by Ivoclar Vivadent AG. The device was registered on April 01, 2020.

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
DE0504300
Ivoclar Dental sealants, pit/fissure
HSA Registration Number: DE0504300
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Product Description

A material intended for sealing pits and fissures on teeth. It may include accessories to complete the sealing procedure.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0504300
Registration Date
April 01, 2020
Change Notification Approval Date
March 01, 2022
Retention Due Date
March 31, 2026
Product Owner
Short Name
Ivoclar Vivadent AG
Address
Bendererstrasse 2, 9494 Schaan, LIECHTENSTEIN
Registrant
Address
100 PECK SEAH STREET, PS100, #08-14, SINGAPORE 079333
Importer
Address
103 KALLANG AVENUE, AIS INDUSTRIAL BUILDING, #06-02, SINGAPORE 339504 180 Paya Lebar Road, Yi Guang Building, #10-03, SINGAPORE 409032
Model Information
Model Name(s)
Helioseal Refill 1x8 g Helioseal Clear Refill 1x1.25 g Helioseal F Plus Refill 1x1.25g Helioseal F Plus Assortment 5x1.25g Helioseal F Plus Cavifil Refill 50x0.1g Helioseal F Plus Refill 1x1g
Model Identifier(s)
533297 558521 686769 686770 686771 686772