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Osstem TS Abutment System (Ti-6Al-4V, PEEK) - HSA Registration DE0510558

Access comprehensive regulatory information for Osstem TS Abutment System (Ti-6Al-4V, PEEK) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510558 and owned by OSSTEM IMPLANT Co., Ltd.. The device was registered on April 04, 2025.

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
DE0510558
Osstem TS Abutment System (Ti-6Al-4V, PEEK)
HSA Registration Number: DE0510558
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Product Description

The abutment system is intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0510558
Registration Date
April 04, 2025
Retention Due Date
April 03, 2026
Product Owner
Short Name
OSSTEM IMPLANT Co., Ltd.
Address
66-16, Bansong-ro 513beon-gil, Haeundae-gu, Busan, 48002, KOREA, REPUBLIC OF
Registrant
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #03-02, SINGAPORE 138565
Importer
Address
29 MEDIA CIRCLE, ALICE@MEDIAPOLIS, #03-02, SINGAPORE 138565
Model Information
Model Name(s)
TS Ti Abutment Screw TS Ti Abutment Screw TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment TS Quick Temporary Abutment
Model Identifier(s)
GSABSMT GSABSST TSQTA4015M TSQTA4015MN TSQTA4015MNTH TSQTA4015MTH TSQTA4050M TSQTA4050MN TSQTA4050MNTH TSQTA4050MTH TSQTA4515R TSQTA4515RN TSQTA4515RNTH TSQTA4515RTH TSQTA4550 TSQTA4550N TSQTA4550NTH TSQTA4550R TSQTA4550RN TSQTA4550RNTH TSQTA4550RTH TSQTA4550TH TSQTA5550 TSQTA5550N TSQTA5550NTH TSQTA5550TH