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GC G-CEM ONE - HSA Registration DE0505570

Access comprehensive regulatory information for GC G-CEM ONE in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505570 and owned by GC CORPORATION. The device was registered on March 16, 2021.

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
DE0505570
GC G-CEM ONE
HSA Registration Number: DE0505570
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Product Description

1. Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges. 2. Cementation of metal, ceramic, fiber posts, cast post and cores. 3. Cementation of all ceramic and composite veneers. 4. Final cementation of crowns and bridges on implant abutments.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0505570
Registration Date
March 16, 2021
Change Notification Approval Date
October 31, 2023
Retention Due Date
March 15, 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)
G-CEM ONE PP Starter Kit A2 G-CEM ONE PP Starter Kit Translucent G-CEM ONE PASTE PAK Self Adhesive Resin Cement Single Refill A2 G-CEM ONE PASTE PAK Self Adhesive Resin Cement Single Refill Translucent G-CEM ONE PASTE PAK Self Adhesive Resin Cement Single Refill AO3 G-CEM ONE PASTE PAK Self Adhesive Resin Cement Single Refill White Opaque G-CEM ONE ADHESIVE ENHANCING PRIMER G-CEM ONE Starter Kit A2 G-CEM ONE Starter Kit Translucent G-CEM ONE Twin Refill A2 G-CEM ONE Twin Refill Translucent G-CEM ONE Single Refill AO3 G-CEM ONE Single Refill White Opaque
Model Identifier(s)
13634 13635 13636 13637 13638 13639 13644 13661 13662 13664 13665 13666 13667