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GC everX Flow - HSA Registration DE0504098

Access comprehensive regulatory information for GC everX Flow in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504098 and owned by GC CORPORATION. The device was registered on February 07, 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
DE0504098
GC everX Flow
HSA Registration Number: DE0504098
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Product Description

everX Flow is a reinforcing dentin replacement material suitable for: 1. All direct composite restorations including large posterior cavities, deep cavities and endo-treated teeth, cavities with missing cusps or after amalgam removal and cavities where inlays and onlays would also be recommended. 2. Core build-up

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0504098
Registration Date
February 07, 2020
Retention Due Date
February 06, 2026
Product Owner
Short Name
GC CORPORATION
Address
3-2-14 HONGO, BUNKYO-KU, TOKYO 113-0033, JAPAN
Registrant
Address
5 TAMPINES CENTRAL 1, TAMPINES PLAZA, #06-01, SINGAPORE 529541
Importer
Address
5 TAMPINES CENTRAL 1, TAMPINES PLAZA, #06-01, SINGAPORE 529541
Model Information
Model Name(s)
everX Flow SYRINGE 3.7g (2.0mL) Bulk Shade everX Flow SYRINGE 3.7g (2.0mL) Dentin Shade
Model Identifier(s)
12898 12899