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DIO Protem Mini System - HSA Registration DE0508896

Access comprehensive regulatory information for DIO Protem Mini System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0508896 and owned by DIO Corporation. The device was registered on January 26, 2024.

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 C
DE0508896
DIO Protem Mini System
HSA Registration Number: DE0508896
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Product Description

Protem Fixture is an endosseous dental implant in order to support prosthetic appliance such as artificial teeth used to recover a patientโ€™s mastication. Protem Fixture is used for masticatory function and aesthetic restoration as implanted in the upper or lower jaw bone of edentulous or partially edentulous patients. Protem Superstructure is used for the recovery of the patientโ€™s masticatory movement, it is intended for use with an endosseous dental implant to support a prosthetic device in a partially or fully of completely edentulous patient. It is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0508896
Registration Date
January 26, 2024
Retention Due Date
January 25, 2026
Product Owner
Short Name
DIO Corporation
Address
66, Centum Seo-ro, Haeundae-gu, 48058, Busan, KOREA, REPUBLIC OF
Registrant
Address
12 MARINA BOULEVARD, MARINA BAY FINANCIAL CENTRE, #17-00, SINGAPORE 018982
Importer
Address
73 UBI ROAD 1, OXLEY BIZHUB, #10-61/62, SINGAPORE 408733
Model Information
Model Name(s)
Protem Ball Cap Protem Cemented Abutment Protem Cemented Abutment Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Ball Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Post Fixture Protem Healing Cap Protem Healing Cap Protem Straight Drill Protem Straight Drill DIOnavi. Straight Drill Protem Straight Drill DIOnavi. Straight Drill DIOnavi. Straight Drill Protem Straight Drill DIOnavi. Straight Drill Protem Straight Drill DIOnavi. Straight Drill Protem Straight Drill DIOnavi. Straight Drill Protem Straight Drill DIOnavi. Straight Drill Protem Straight Drill DIOnavi. Straight Drill Protem Straight Drill DIOnavi. Straight Drill Protem Straight Drill DIOnavi. Straight Drill Protem Straight Drill DIOnavi. Straight Drill Protem Straight Drill Protem Tissue Punch Protem Tissue Punch Protem Tissue Punch Protem O-Ring Protem Surgical Kit Protem Surgical Kit Protem Surgical Kit Protem Tissue Punch DIOnavi. Bone Flattening Drill
Model Identifier(s)
MBC 3803 MCB 3508 MCB 3512 MFB 20210 MFB 20212 MFB 20214 MFB 20410 MFB 20412 MFB 20414 MFB 25210 MFB 25212 MFB 25214 MFB 25410 MFB 25412 MFB 25414 MFB 30210A MFB 30212A MFB 30214A MFB 30216A MFB 30410A MFB 30412A MFB 30414A MFB 30416A MFP 20208 MFP 20210 MFP 20212 MFP 20214 MFP 20408 MFP 20410 MFP 20412 MFP 20414 MFP 25208 MFP 25210 MFP 25212 MFP 25214 MFP 25408 MFP 25410 MFP 25412 MFP 25414 MFP 30210A MFP 30212A MFP 30214A MFP 30216A MFP 30410A MFP 30412A MFP 30414A MFP 30416A MHC 5006 MHC 5008 MSD 1212 MSD 1218 MSD 1218D MSD 1218M MSD 1505D MSD 1509D MSD 1512 MSD 1514D MSD 1518 MSD 1518D MSD 1518M MSD 2009D MSD 2012 MSD 2014D MSD 2018 MSD 2018D MSD 2018M MSD 2509D MSD 2512 MSD 2514D MSD 2518 MSD 2518D MSD 2518M MTP 2510 MTP 3010 MTP 3510 OR 3401 PRT 00 PRT 02 PRT(M) 00 PTP 20 UBFD 3430