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Osstem Implant Surgical Procedure Kit - HSA Registration DE0012634

Access comprehensive regulatory information for Osstem Implant Surgical Procedure Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0012634 and owned by OSSTEM IMPLANT CO LTD. The device was registered on March 25, 2013.

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
DE0012634
Osstem Implant Surgical Procedure Kit
HSA Registration Number: DE0012634
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Product Description

A collection of various dental instruments designed for the surgical placement of dental implants or prostheses. It does not contain pharmaceuticals. It typically contains various dental drills (drill bits), drill extensions, depth gauges, wrenches and torque wrench, screwdrivers, forceps, trays and osteotomes.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
HSA Product Code
HSAMDB00103
HS Code
90212900
Registration Information
Registration Number
DE0012634
Registration Date
March 25, 2013
Change Notification Approval Date
January 19, 2023
Retention Due Date
March 24, 2026
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)
123 Cortical Drill 123 Cortical Drill 123 Cortical Drill 123 Cortical Drill 123 Twist Drill 123 Twist Drill 123 Twist Drill 123 Twist Drill 123 Twist Drill 123 Twist Drill 123 Twist Drill 123 Twist Drill 123 Cortical Drill 123 Cortical Drill 123 Cortical Drill 123 Cortical Drill Autobone Collector Autobone Collector Autobone Collector Autobone Collector Autobone Collector Autobone Collector Autobone Collector Autobone Collector Autobone Collector Drill SET Autobone Collector Drill SET Autobone Collector Drill SET Autobone Collector Drill SET Autobone Collector Drill SET Autobone Collector Drill SET Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Autobone Collector Drill Drill Extension Simple Mount Driver Simple Mount Driver 123 Guide Drill Osstem123 KIT SideCut Drill Nomount Driver Nomount Driver Nomount Driver
Model Identifier(s)
2CD35 2CD40 2CD45 2CD50 2D2230L 2D2230S 2D3036L 2D3036S 2D3041L 2D3041S 2D3046L 2D3046S 3CD35 3CD40 3CD45 3CD50 ABC2D304L ABC2D304S ABC2D404L ABC2D404S ABC304L ABC304S ABC404L ABC404S ABC504L ABC504S ABC604L ABC604S ABC704L ABC704S ABCD2D504L ABCD2D504S ABCD2D604L ABCD2D604S ABCD2D704L ABCD2D704S ABCD3014S ABCD3017L ABCD3514S ABCD3517L ABCD4014S ABCD4017L ABCD4514S ABCD4517L ABCD5014S ABCD5017L ABCD6014S ABCD6017L ABCD7014S ABCD7017L ADE ASMDL ASMDS GD2027L H123K OSLMD20L SSNOMD39RS TSNMDML TSNMDRL