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Osstem GBR Kit - HSA Registration DE0504148

Access comprehensive regulatory information for Osstem GBR 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 DE0504148 and owned by OSSTEM IMPLANT Co., Ltd.. The device was registered on February 24, 2020.

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
DE0504148
Osstem GBR Kit
HSA Registration Number: DE0504148
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Product Description

The GBR kit is a collection of bone tack and bone screw instruments used to secure the barrier membrane during dental implant procedures.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0504148
Registration Date
February 24, 2020
Change Notification Approval Date
January 19, 2023
Retention Due Date
February 23, 2026
Product Owner
Short Name
OSSTEM IMPLANT Co., Ltd.
Address
66-16 Bansong-ro 513 beon-gil, Haeundae-gu, Busan, Korea 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)
GBR KIT
Model Identifier(s)
ONGBRK