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Osstem Dental Procedure Handpiece, Line-Powered - HSA Registration DE0507819

Access comprehensive regulatory information for Osstem Dental Procedure Handpiece, Line-Powered in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507819 and owned by Osstem Implant Co., Ltd.. The device was registered on February 24, 2023.

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
DE0507819
Osstem Dental Procedure Handpiece, Line-Powered
HSA Registration Number: DE0507819
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Product Description

A hand-held dental device that includes a chuck or collet for attaching a dental drill, bur, reamer, and other similar rotating instruments used to bore/excavate bones, teeth, and tough tissues in dentistry. It is powered by a low-voltage electric micro-motor that is an integral part of the device.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0507819
Registration Date
February 24, 2023
Retention Due Date
February 23, 2026
Product Owner
Short Name
Osstem Implant Co., Ltd.
Address
3, Magokjungang 12-ro, Gangseo-Gu, Seoul, 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)
Osstem E200IL Osstem E205IL Osstem E400I
Model Identifier(s)
E200IL E205IL E400I