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GC Gradia Plus - HSA Registration DE0502670

Access comprehensive regulatory information for GC Gradia Plus in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502670 and owned by GC CORPORATION. The device was registered on January 09, 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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CLASS B
DE0502670
GC Gradia Plus
HSA Registration Number: DE0502670
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Product Description

The Gradia Plus is a modular composite system for indirect restorations are to be used only by a dental professional in the recommended indications: 1. Crown and bridgework (with metal backing) 2. Metal free restorations: Jacket crowns, inlays, onlays and laminated veneers 3. Implant superstructures 4. Reproduction of gum tissue for crown restorations

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0502670
Registration Date
January 09, 2019
Change Notification Approval Date
May 03, 2019
Retention Due Date
January 08, 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)
GC Metal Primer Z 5mL GRADIA PLUS Layer Set GRADIA PLUS Paint Set GRADIA PLUS Gum Shades Set GRADIA PLUS ONE BODY SET GRADIA PLUS Accessory Set GRADIA PLUS Opaque 2mL O-Base GRADIA PLUS Opaque 2mL OA GRADIA PLUS Opaque 2mL OB GRADIA PLUS Opaque 2mL OC GRADIA PLUS Opaque 2mL OD GRADIA PLUS Opaque 2mL OA1 GRADIA PLUS Gum Shades Opaque 2mL GO-1 GRADIA PLUS Gum Shades Opaque 2mL GO-2 GRADIA PLUS Paste Heavy Body 3.3mL HB-DA1 GRADIA PLUS Paste Heavy Body 3.3mL HB-DA2 GRADIA PLUS Paste Heavy Body 3.3mL HB-DA3 GRADIA PLUS Paste Heavy Body 3.3mL HB-DA3.5 GRADIA PLUS Paste Heavy Body 3.3mL HB-DB1 GRADIA PLUS Paste Heavy Body 3.3mL HB-DB3 GRADIA PLUS Paste Heavy Body 3.3mL HB-DC3 GRADIA PLUS Paste Heavy Body 3.3mL HB-DD2 GRADIA PLUS Paste Heavy Body 3.3mL HB-EL GRADIA PLUS Paste Heavy Body 3.3mL HB-ED GRADIA PLUS Paste Heavy Body 3.3mL HB-CLF GRADIA PLUS Paste Heavy Body 3.3mL HB-PE GRADIA PLUS Paste Heavy Body 3.3mL HB-ODA GRADIA PLUS Paste Heavy Body 3.3mL HB-ODB GRADIA PLUS Paste Heavy Body 3.3mL HB-ODC GRADIA PLUS Paste Heavy Body 3.3mL HB-ODD GRADIA PLUS Paste Heavy Body 3.3mL HB-ODW GRADIA PLUS Paste Heavy Body 3.3mL HB-DW GRADIA PLUS Gum Shades Heavy Body 3.3 mL GHB-1 GRADIA PLUS Gum Shades Heavy Body 3.3mL GHB-2 GRADIA PLUS Gum Shades Heavy Body 3.3mL GHB-3 GRADIA PLUS Gum Shades Heavy Body 3.3mL GHB-CL GRADIA PLUS Paste Light Body 2mL LB-Base E GRADIA PLUS Paste Light Body 2mL LB-Base CLF GRADIA PLUS Paste Light Body 2mL LB-Base D GRADIA PLUS Paste Light Body 2mL LB-DW GRADIA PLUS Paste Light Body 2mL LB-Base OD GRADIA PLUS Paste Light Body 2mL LB-ODW GRADIA PLUS Paste Light Body 2mL LB-Base Opal GRADIA PLUS Paste Light Body 2mL LB-Orange GRADIA PLUS Paste Light Body 2mL LB-Yellow GRADIA PLUS Paste Light Body 2mL LB-Red GRADIA PLUS Paste Light Body 2mL LB-Grey GRADIA PLUS Paste Light Body 2mL LB-Blue GRADIA PLUS Paste Light Body 2mL LB-Milky GRADIA PLUS Paste Light Body 2mL LB-Inlay E GRADIA PLUS Paste Light Body 2mL LB-Inlay TD GRADIA PLUS ONE BODY 2mL LB-A GRADIA PLUS ONE BODY 2mL LB-B GRADIA PLUS ONE BODY 2mL LB-C GRADIA PLUS ONE BODY 2mL LB-D GRADIA PLUS ONE BODY 2mL LB-W GRADIA PLUS Gum Shades Light Body 2mL GLB-1 GRADIA PLUS Gum Shades Light Body 2mL GLB-2 GRADIA PLUS Gum Shades Light Body 2mL GLB-3 GRADIA PLUS Gum Shades Light Body 2mL GLB-CL GRADIA PLUS Lustre Paint 0.8mL LP-A GRADIA PLUS Lustre Paint 0.8mL LP-B GRADIA PLUS Lustre Paint 0.8mL LP-C GRADIA PLUS Lustre Paint 0.8mL LP-D GRADIA PLUS Lustre Paint 0.8mL LP-CLF GRADIA PLUS Lustre Paint 0.8mL LP-Blue GRADIA PLUS Lustre Paint 0.8mL LP-Grey GRADIA PLUS Lustre Paint 0.8mL LP-Cream GRADIA PLUS Lustre Paint 0.8mL LP-Lavender GRADIA PLUS Lustre Paint 0.8mL LP-CL GRADIA PLUS Gum Shades LP 0.8mL GLP-Bright Red GRADIA PLUS Gum Shades LP 0.8mL GLP-Violet GRADIA PLUS Lustre Paint Diluting Liquid 3mL GRADIA PLUS AIR BARRIER 10mL GRADIA PLUS Modeling Liquid 3mL GRADIA PLUS SEPARATOR 5mL GRADIA PLUS DTip PTWide & LPcover, 5pcs GRADIA PLUS DTIP Ntype S & LPcover, 5pcs GRADIA PLUS DTIP Ntype & LPcover, 5pcs GRADIA PLUS Mixotip, 10pcs GC Acrylic Primer 6mL GRADIA PLUS Layer Pro Set
Model Identifier(s)
009295 901048 901050 901051 901052 901053 901054 901055 901056 901057 901058 901059 901067 901068 901069 901070 901071 901072 901073 901074 901075 901076 901077 901078 901079 901080 901081 901082 901083 901084 901085 901086 901087 901088 901089 901090 901091 901092 901093 901094 901095 901096 901097 901098 901099 901100 901101 901102 901103 901104 901105 901106 901107 901108 901109 901110 901111 901112 901113 901114 901115 901116 901117 901118 901119 901120 901121 901122 901123 901124 901125 901126 901127 901128 901129 901130 901133 901134 901135 901136 901138 901409