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Osstem Dental Implant System - HSA Registration DE0010520

Access comprehensive regulatory information for Osstem Dental Implant System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0010520 and owned by OSSTEM IMPLANT CO LTD. The device was registered on September 10, 2012.

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
DE0010520
Osstem Dental Implant System
HSA Registration Number: DE0010520
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Product Description

The Osstem Implant system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including: cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. The abutment is intended for use with a dental implant fixture to provide support for prosthetic restoration such as crown, bridge, or overdenture.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
HSA Product Code
Refer to CRPNS
HS Code
90184900
Registration Information
Registration Number
DE0010520
Registration Date
September 10, 2012
Change Notification Approval Date
January 19, 2023
Retention Due Date
September 09, 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)
THREE CUTTER TWIST DRILL DIRECT DRILL DIRECT DRILL DIRECT DRILL DIRECT DRILL CORTICAL DRILL CORTICAL DRILL GS PROSTHETIC KIT CAS KIT LAS KIT LAS KIT_Bone Separator LASK-Drill LASK-Drill LASK-Drill LASK-Drill LASK-Drill LAS KIT_Stopper LAS KIT_Stopper LAS KIT_Stopper LAS KIT_Stopper LAS KIT_Stopper LAS KIT_Stopper OsstemGuide KIT SURGICAL TAP SURGICAL TAP OsstemGuide Cuntersink REMOVAL BUR MOUNT DRIVER ORTHODONTIC SCREW MACHINE DRIVER SCREW REMOVAL KIT TISSUE PUNCH TAPER SIMPLE KIT OsstemGuide Anchor Twist Drill OSSTEMGUIDE CORTICAL DRILL 2 OSSTEMGUIDE CORTICAL DRILL 2 OSSTEMGUIDE CORTICAL DRILL 2 OSSTEMGUIDE CORTICAL DRILL 2 OsstemGuide Cortical Drill 3 OsstemGuide Cortical Drill 3 OsstemGuide Cortical Drill 3 OsstemGuide Cortical Drill 3 OsstemGuide Initial Drill OsstemGuide Initial Drill OsstemGuide Initial Drill OSSTEMGUIDE TWIST DRILL OsstemGuide Twist Drill OsstemGuide Twist Drill OsstemGuide Twist Drill OsstemGuide Twist Drill OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OsstemGuide Twist Drill OsstemGuide Twist Drill OsstemGuide Twist Drill OsstemGuide Twist Drill OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OsstemGuide Twist Drill OsstemGuide Twist Drill OsstemGuide Twist Drill OsstemGuide Twist Drill OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OsstemGuide Twist Drill OsstemGuide Twist Drill OsstemGuide Twist Drill OsstemGuide Twist Drill OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OsstemGuide Twist Drill OsstemGuide Twist Drill OsstemGuide Twist Drill OsstemGuide Twist Drill OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OSSTEMGUIDE TWIST DRILL OsstemGuide Tissue Punch OsstemGuide Tissue Punch OsstemGuide Tissue Punch OsstemGuide Tissue Punch CAS Drill CAS Drill CAS Drill CAS Drill CAS Drill CAS Drill CAS Drill SS NOMOUNT DRIVER SS NOMOUNT DRIVER LAS KIT_Side Wall Drill TWIST DRILL TWIST DRILL TWIST DRILL US NOMOUNT DRIVER US NOMOUNT DRIVER NOMOUNT DRIVER US NOMOUNT DRIVER NOMOUNT DRIVER NOMOUNT DRIVER OSSTEMGUIDE COUNTERSINK OSSTEMGUIDE COUNTERSINK
Model Identifier(s)
3D3013FNLC 3D5213FNLC 3D5510FNLC 3D6213FNLC 3D6510FNLC CD4C60 CD4C70 GSPK HCRSNK HLRSNK HST75 LSDR554TC LSDR554TD LSDR74TC LSDR74TD LSDR74WTD LSNST0.5 LSNST1.0 LSNST1.5 LSNST2.0 LSNST2.5 LSNST3.0 OGDK OGST60LC OGST70LC OGUSCS45W ORB OSMD OSMDA OSSVK OSTP33 OTSSK QGATD13 QGCD235M QGCD240R QGCD245R QGCD250W QGCD335M QGCD340R QGCD345R QGCD350W QGID20M QGID20R QGID20W QGTD2007 QGTD2008 QGTD2010 QGTD2011 QGTD2013 QGTD2015 QGTD3007 QGTD3008 QGTD3010 QGTD3011 QGTD3013 QGTD3015 QGTD3307 QGTD3308 QGTD3310 QGTD3311 QGTD3313 QGTD3315 QGTD3607 QGTD3608 QGTD3610 QGTD3611 QGTD3613 QGTD3615 QGTD3807 QGTD3808 QGTD3810 QGTD3811 QGTD3813 QGTD3815 QGTD4107 QGTD4108 QGTD4110 QGTD4111 QGTD4113 QGTD4115 QGTD4307 QGTD4308 QGTD4310 QGTD4311 QGTD4313 QGTD4315 QGTD4607 QGTD4608 QGTD4610 QGTD4611 QGTD4613 QGTD4615 QGTP33M QGTP38R QGTP47R QGTP53W SNDR2813T SNDR3113T SNDR3313T SNDR3613T SNDR3813T SNDR4113T SNTD2013T SSNOMD39RL SSNOMD39RS SWDR36T TDE2010L TDE2011L TDE2013FNLC USNMD35ML USNMD35MS USNMD41RL USNMD41RS USNMD51WL USNMD51WS USSCS45W USTCS45W