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GC Dental Crowns / Bridges - HSA Registration DE0507631

Access comprehensive regulatory information for GC Dental Crowns / Bridges in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507631 and owned by GC Europe N.V.. The device was registered on December 22, 2022.

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
DE0507631
GC Dental Crowns / Bridges
HSA Registration Number: DE0507631
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Product Description

A material used to manufacture partial or full crowns and bridges

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0507631
Registration Date
December 22, 2022
Change Notification Approval Date
March 11, 2024
Retention Due Date
December 21, 2025
Product Owner
Short Name
GC Europe N.V.
Address
Interleuvenlaan 33, 3001 Leuven, BELGIUM
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 Initial Spectrum Stain SPS-1, 3g, Ivory White GC Initial Spectrum Stain SPS-2, 3g, Mellon Yellow GC Initial Spectrum Stain SPS-3, 3g, Signal Yellow GC Initial Spectrum Stain SPS-4, 3g, Light Terracotta GC Initial Spectrum Stain SPS-5, 3g, Savanah Gold GC Initial Spectrum Stain SPS-6, 3g, Caramel GC Initial Spectrum Stain SPS-7, 3g, Camel GC Initial Spectrum Stain SPS-8, 3g, Olive GC Initial Spectrum Stain SPS-9, 3g, Brown GC Initial Spectrum Stain SPS-10, 3g, Dark Walnut GC Initial Spectrum Stain SPS-11, 3g, Coral GC Initial Spectrum Stain SPS-12, 3g, Denim Blue GC Initial Spectrum Stain SPS-13, 3g, Denim Blue GC Initial Spectrum Stain SPS-14, 3g, Deep Orange GC Initial Spectrum Stain SPS-15, 3g, Sunset GC Initial Spectrum Stain SPS-16, 3g, Midnight GC Initial Spectrum Stain SPS-17, 3g, Dark Brown GC Initial Spectrum Stain SPS-18, 3g, Illusion 1 GC Initial Spectrum Stain SPS-19, 3g, Illusion 2 GC Initial Spectrum Stain SPS-20, 3g, Illusion 3 GC Initial Spectrum Glaze GL-FLUO,10g GC Initial Spectrum Glaze Liquid, 25ml GC Initial Spectrum Glaze Powder GL, 10g GC Initial Spectrum Glaze Paste Liquid, 8ml GC Initial IQ LP ONE, Diluting Liquid, 8ml GC Initial IQ LP ONE, Refresh Liquid, 8ml GC Initial IQ/LP ONE,L-A, 4g GC Initial IQ/LP ONE, L-B, 4g GC Initial IQ/LP ONE, L-C, 4g GC Initial IQ/LP ONE, L-D, 4g GC Initial IQ/LP ONE, L-N, 4g GC Initial IQ/LP ONE, L-1, 4g GC Initial IQ/LP ONE, L-2, 4g GC Initial IQ/LP ONE, L-3, 4g GC Initial IQ/LP ONE, L-4, 4g GC Initial IQ/LP ONE, L-5, 4g GC Initial IQ/LP ONE, L-6, 4g GC Initial IQ/LP ONE, L-7, 4g GC Initial IQ/LP ONE, L-8, 4g GC Initial IQ/LP ONE, L-9, 4g GC Initial IQ/LP ONE, L-10, 4g GC Initial IQ/LP ONE,E L-V, 4g GC Initial IQ/LP ONE, L-OP, 4g GC Initial IQ/LP ONE, L-NFL, 4g GC Initial IQ,LP ONE,L-N, 12g GC Initial IQ,LP ONE, L-NFL, 12g Initial IQ,SQIN Body-A,10g Initial IQ,SQIN Body-B,10g Initial IQ,SQIN Body-C,10g Initial IQ,SQIN Body-D,10g Initial IQ,SQIN Body BL-D,10g Initial IQ,SQIN E-57, 10g Initial IQ,SQIN E-58, 10g Initial IQ,SQIN E-59, 10g Initial IQ,SQIN E-60, 10g Initial IQ,SQIN BL-E, 10g Initial IQ,SQIN TO-Booster, 10g Initial IQ,SQIN GUM light, 10g Initial IQ,SQIN GUM dark, 10g Initial IQ, SQIN GUM neutral, 10g Initial IQ; SQIN Form & Texture Liquid, 50ml GC Initial Spectrum Stain Set,90g GC Initial IQ/LP ONE,V-SHADES Set,88g Initial IQ,SQIN SHADES SET,140g GC Initial IQ, One SQIN System Set
Model Identifier(s)
876151 876152 876153 876154 876155 876156 876157 876158 876159 876160 876161 876162 876163 876164 876165 876166 876167 876168 876169 876170 876171 876180 876181 876182 876449 876450 876451 876452 876453 876454 876455 876456 876457 876458 876459 876460 876461 876462 876463 876464 876465 876466 876467 876468 876469 876470 876480 876481 876482 876483 876484 876485 876486 876487 876488 876489 876490 876491 876492 876493 876495 877094 877096 877097 877098