Singapore HSA registration DE0502939

GC G-aenial Universal Injectable

Singapore·CLASS B·GC CORPORATION·Registered March 28, 2019

Device classification

Device Class: CLASS B
Medical Speciality Area: Dental

Registration information

Registration Number: DE0502939
Registration Date: March 28, 2019
Change Notification Approval Date: September 16, 2019
Retention Due Date: March 27, 2026

Product description

1. Direct restorative for Class I, II, III, IV and V cavities 2. Fissure sealant 3. Sealing hypersensitive areas 4. Repair of (in)direct aesthetic restorations, temporary crown & bridge, defect margins when margins are in enamel 5. Blocking out undercuts 6. Liner or base 7. Core Build-up

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): DISPENSING TIP LONG NEEDLE G-aenial Universal Injectable, Syringe 1.7g (1.0mL) A1 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) A2 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) A3 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) A3.5 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) A4 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) B1 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) B2 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) CV G-aenial Universal Injectable, Syringe 1.7g (1.0mL) CVD G-aenial Universal Injectable, Syringe 1.7g (1.0mL) AO1 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) AO2 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) AO3 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) JE G-aenial Universal Injectable, Syringe 1.7g (1.0mL) AE G-aenial Universal Injectable, Syringe 1.7g (1.0mL) XBW G-aenial Universal Injectable, Syringe 1.7g (1.0mL) BW G-aenial Universal Injectable, Syringe 1.7g (1.0mL) A1 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) A2 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) A3 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) A3.5 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) A4 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) B1 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) B2 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) CV G-aenial Universal Injectable, Syringe 1.7g (1.0mL) CVD G-aenial Universal Injectable, Syringe 1.7g (1.0mL) AO1 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) AO2 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) AO3 G-aenial Universal Injectable, Syringe 1.7g (1.0mL) JE G-aenial Universal Injectable, Syringe 1.7g (1.0mL) AE G-aenial Universal Injectable, Syringe 1.7g (1.0mL) XBW G-aenial Universal Injectable, Syringe 1.7g (1.0mL) BW
Model Identifier(s): 012281 012308 012309 012310 012311 012312 012313 012314 012315 012316 012317 012318 012319 012320 012321 012322 012323 012364 012365 012366 012367 012368 012369 012370 012371 012372 012373 012374 012375 012376 012377 012378 012379

About this record

Access comprehensive regulatory information for GC G-aenial Universal Injectable in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502939 and owned by GC CORPORATION. The device was registered on March 28, 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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