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Osstem Implant SM5 System - HSA Registration DE0019063

Access comprehensive regulatory information for Osstem Implant SM5 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 DE0019063 and owned by Osstem Implant Co., Ltd.. The device was registered on March 20, 2017.

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
DE0019063
Osstem Implant SM5 System
HSA Registration Number: DE0019063
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Product Description

Intended only for use in the field of dentistry, for surgery to expose and dissect oral tissue structures or endodontic treatments (e.g. periodontal gap, gingiva, bone, jaw, extractions, implantations)

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0019063
Registration Date
March 20, 2017
Change Notification Approval Date
September 19, 2023
Retention Due Date
March 19, 2026
Product Owner
Short Name
Osstem Implant Co., Ltd.
Address
3, Magokjungang 12-ro, Gangseo-Gu, Seoul, 07789, 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)
INTRA LUX S600 LED SURGmatic S201 L Motor cable S600 Handpiece tray Hose set steile S600 Foot control Sterilizable hose set S600 SM5 SURGmatic S201 L Pro
Model Identifier(s)
1.008.8000 1.009.0470 1.009.1700 1.009.3411 1.009.8757 1.010.0288 1.011.0633 1.011.4900 1.013.7540