Singapore HSA registration DE0019063
Osstem Implant SM5 System
Singapore·CLASS B·Osstem Implant Co., Ltd.·Registered March 20, 2017Device 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 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)
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
About this record
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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