Singapore HSA registration DE0505555
GC G2-BOND Universal
Singapore·CLASS B·GC CORPORATION·Registered March 10, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0505555
- Registration Date
- March 10, 2021
- Change Notification Approval Date
- March 30, 2021
- Retention Due Date
- March 09, 2026
Product description
1. Direct bonding of light-cured composites and compomers to tooth structure 2. Bonding of dual-cured core build up composites to tooth structure as long as these materials are light-cured 3. Intraoral repair of composite, metal-based and zirconia / alumina-based restorations 4. Intraoral repair of ceramic restorations in combination with a silane coupling agent 5. Treatment of hypersensitive teeth 6. Sealing of tooth preparation (cavity or abutment) for indirect restorations 7. Treatment of exposed root surfaces 8. Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges and veneers 9. Post cementation
Product Owner
- Name
- GC CORPORATION
- 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)
- G2-BOND Universal Bottle Kit G2-BOND Universal 1-PRIMER Refill 5ml G2-BOND Universal 2-BOND Refill 5ml
- Model Identifier(s)
- 13645 13649 13650
About this record
Access comprehensive regulatory information for GC G2-BOND Universal in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505555 and owned by GC CORPORATION. The device was registered on March 10, 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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