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Genoss Dental Restorative/Repair Materials - HSA Registration DE0506494

Access comprehensive regulatory information for Genoss Dental Restorative/Repair Materials in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506494 and owned by Genoss Co., Ltd.. The device was registered on December 20, 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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CLASS B
DE0506494
Genoss Dental Restorative/Repair Materials
HSA Registration Number: DE0506494
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Product Description

A substance intended to fill dental cavities, seal pits and fissures, restore damaged dental tissues, or for inlays, onlays and veneering. It may include accessories that are used specifically with the materials. It does not include obturation of root canal.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0506494
Registration Date
December 20, 2021
Retention Due Date
December 19, 2025
Product Owner
Short Name
Genoss Co., Ltd.
Address
1F, Gyeonggi R&DB Center / 226, 2F, GSBC, 105 Gwanggyo-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, KOREA, REPUBLIC OF
Registrant
Address
20 HARBOUR DRIVE, PSA VISTA, #07-06, SINGAPORE 117612
Importer
Address
20 HARBOUR DRIVE, PSA VISTA, #07-06, SINGAPORE 117612
Model Information
Model Name(s)
Bright High Flow Bright High Flow Bright High Flow Bright High Flow Bright High Flow Bright High Flow Bright High Flow Bright High Flow Bright High Flow Bright Low Flow Bright Low Flow Bright Low Flow Bright Low Flow Bright Low Flow Bright Low Flow Bright Low Flow Bright Low Flow Bright Low Flow
Model Identifier(s)
HFA1 HFA2 HFA3 HFA3.5 HFA4 HFBW HFCV HFOA2 HFOA3 LFA1 LFA2 LFA3 LFA3.5 LFA4 LFBW LFCV LFOA2 LFOA3