Singapore HSA registration DE0501399
GC RELINE II
Singapore·CLASS B·GC CORPORATION·Registered March 16, 2018Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0501399
- Registration Date
- March 16, 2018
- Retention Due Date
- March 15, 2026
Product description
The GC Reline™ II is for use only by a dental professional in the recommended indications: • Relining of dentures in case of thin sensitive mucosa and resorbed ridges • Relining of dentures in case of sharp and bony ridges • Relining of dentures in case of bony undercuts (with difficulties involving insertion and/or removal of the denture) • Relining of implant-supported dentures
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)
- GC RELINE II Soft INTRODUCTORY KIT GC RELINE II ExtraSoft INTRODUCTORY KIT GC RELINE II Soft CARTRIDGE GC RELINE II ExtraSoft CARTRIDGE GC RELINE II FINISHING MATERIAL GC RELINE II PRIMER FOR RESIN GC RELINE II REMOVER FOR RESIN GC RELINE II POINT FOR TRIMMING GC RELINE II WHEEL FOR FINISHING DISPOSABLE BRUSH
- Model Identifier(s)
- 010259 010262 010265 010268 010271 010273 010275 010277 010280 010283
About this record
Access comprehensive regulatory information for GC RELINE II in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0501399 and owned by GC CORPORATION. The device was registered on March 16, 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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