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Osstem Port Abutment system - HSA Registration DE0016209

Access comprehensive regulatory information for Osstem Port Abutment 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 DE0016209 and owned by OSSTEM IMPLANT CO LTD. The device was registered on August 21, 2014.

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
DE0016209
Osstem Port Abutment system
HSA Registration Number: DE0016209
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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
HSA Product Code
HSAMDC00103
HS Code
90212900
Registration Information
Registration Number
DE0016209
Registration Date
August 21, 2014
Change Notification Approval Date
July 18, 2024
Retention Due Date
August 20, 2025
Product Owner
Short Name
OSSTEM IMPLANT CO LTD
Address
66-16 Bansong-ro 513 beon-gil, Haeundae-gu Busan 612-070, 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)
Port Extended Male Port Extended Male Port Extended Male Port Extended Male Port Male Port Male Port Male Port Male Port Male Port Male Port Male Port Male Port Male Cap Port Male Cap Port Male Kit Port Provisional Male Port Provisional Male Spacer Spacer SS Port Abutment SS Port Abutment SS Port Abutment SS Port Abutment SS Port Abutment SS Port Abutment SS Port Abutment TS Port Abutment TS Port Abutment TS Port Abutment TS Port Abutment TS Port Abutment TS Port Abutment TS Port Abutment TS Port Abutment TS Port Abutment TS Port Abutment TS Port Abutment TS Port Abutment TS Port Abutment TS Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment US Port Abutment
Model Identifier(s)
PTCEM06 PTCEM06S PTCEM12 PTCEM12S PTCM04 PTCM04S PTCM06 PTCM06S PTCM12 PTCM12S PTCM22 PTCM22S PTCMC PTCMCB PTCMK PTCPM PTCPMS PTCS PTCSS SSPTA4810R SSPTA4820R SSPTA4830R SSPTA4840R SSPTA4850R SSPTA4860R SSPTA4870R TSPTA3510M TSPTA3520M TSPTA3530M TSPTA3540M TSPTA3550M TSPTA3560M TSPTA3570M TSPTA4010R TSPTA4020R TSPTA4030R TSPTA4040R TSPTA4050R TSPTA4060R TSPTA4070R USPTA3510M USPTA3520M USPTA3530M USPTA3540M USPTA3550M USPTA3560M USPTA3570M USPTA4010R USPTA4020R USPTA4030R USPTA4040R USPTA4050R USPTA4060R USPTA4070R USPTA5010W USPTA5020W USPTA5030W USPTA5040W USPTA5050W USPTA5060W USPTA5070W