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GC Gold Label VII EP Capsule - HSA Registration DE0503134

Access comprehensive regulatory information for GC Gold Label VII EP Capsule in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0503134 and owned by GC CORPORATION. The device was registered on May 22, 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.

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CLASS B
DE0503134
GC Gold Label VII EP Capsule
HSA Registration Number: DE0503134
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Product Description

The GC Gold Label VII EP Capsule is a radiopaque Glass Ionomer Protection and Temporary Restorative Material with CPP-ACP is for use only by a dental professional in the recommended indications: 1. Root surface protection 2. Fissure protection 3. Hypersensitivity prevention and control 4. Protection for immature enamel 5. Temporary filling of endodontic access 6. Intermediate restorations

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0503134
Registration Date
May 22, 2019
Retention Due Date
May 21, 2025
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)
GC Gold Label VII EP CAPSULE PINK GC Gold Label VII EP CAPSULE WHITE
Model Identifier(s)
012709 012710