GC TEMPSMART - HSA Registration DE0501269

Access comprehensive regulatory information for GC TEMPSMART in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501269 and owned by GC CORPORATION. The device was registered on February 22, 2018.

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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HSA Official Data

CLASS B

DE0501269

GC TEMPSMART

HSA Registration Number: DE0501269

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Product Description

1. Fabrication of temporary crowns, bridges, inlays, onlays and veneers 2. Fabrication of long-term temporary restorations

Device Classification

Device Class

CLASS B

Medical Speciality Area

Dental

Registration Information

Registration Number

DE0501269

Registration Date

February 22, 2018

Retention Due Date

February 21, 2026

Product Owner

Name

GC CORPORATION

Short Name

GC CORPORATION

Address

3-2-14 HONGO, BUNKYO-KU, TOKYO 113-0033, JAPAN

Registrant

Name

GC ASIA DENTAL PTE LTD

Address

5 TAMPINES CENTRAL 1, TAMPINES PLAZA, #06-01, SINGAPORE 529541

Importer

Name

GC ASIA DENTAL PTE LTD

Address

5 TAMPINES CENTRAL 1, TAMPINES PLAZA, #06-01, SINGAPORE 529541

Model Information

Model Name(s)

TEMPSMART 48mL Cartridge A1 TEMPSMART 48mL Cartridge A2 TEMPSMART 48mL Cartridge A3 TEMPSMART 48mL Cartridge A3.5 TEMPSMART 48mL Cartridge B1 TEMPSMART 48mL Cartridge BW TEMPSMART 10mL Cartridge A1 TEMPSMART 10mL Cartridge A2 TEMPSMART 10mL Cartridge A3 TEMPSMART 10mL Cartridge B1

Model Identifier(s)

009392 009393 009394 009395 009396 009397 009398 009399 009400 009401