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Dentium SimpleLine II Dental Implant System - HSA Registration DE0510090

Access comprehensive regulatory information for Dentium SimpleLine II Dental Implant System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510090 and owned by Dentium Co., Ltd. The device was registered on November 29, 2024.

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 C
DE0510090
Dentium SimpleLine II Dental Implant System
HSA Registration Number: DE0510090
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Product Description

The Dentium Implant System is designed to be used in dental implant surgery and is surgically placed on the maxillary or mandibular alveolar bone. After osseointegration with the alveolar bone, the defective tooth can be replaced by connecting it to the abutment. It is used to make temporary or final prosthesis in the cent-retained type, screw- retained type, overdenture type and fixed bridge type to replace single or multiple teeth in the maxilla and mandible or in the entire edentulous patient. Abutments are used for securing to fixtures to support prosthetic restorations such as crowns, bridges, and overdenture

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0510090
Registration Date
November 29, 2024
Retention Due Date
November 28, 2025
Product Owner
Short Name
Dentium Co., Ltd
Address
76, Changnyong-daero, 256beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do 16229, KOREA, REPUBLIC OF
Registrant
Address
20 HARBOUR DRIVE, PSA VISTA, #07-06, SINGAPORE 117612
Importer
Address
20 HARBOUR DRIVE, PSA VISTA, #07-06, SINGAPORE 117612
Model Information
Model Name(s)
Reamer Guide Reamer Guide Reamer Guide Reamer Handle Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Maxillofacial Fixture Reamer Guide Reamer Angled Abutment Angled Abutment Angled Abutment Angled Abutment Abutment Screw Ball Abutment Ball Abutment SCA Abutment SCA Abutment SCA Abutment SCA Abutment SCA Abutment SCA Abutment SCA Abutment SCA Abutment SCA Abutment SCA Abutment SCA Abutment SCA Abutment Analog Analog Analog Analog Analog Analog Cover Screw Cover Screw Dual Abutment Dual Abutment Dual Abutment Dual Abutment Dual Abutment Dual Abutment Dual Abutment Dual Abutment Dual Abutment Dual Abutment Dual Abutment Dual Abutment Burn-out Cylinder Burn-out Cylinder Burn-out Cylinder Burn-out Cylinder Comfort Cap Comfort Cap Comfort Cap Comfort Cap Comfort Cap Comfort Cap Impression Coping Impression Coping Impression Coping Screw P Impression Coping P Impression Coping P Impression Coping P Impression Coping P Impression Coping T Impression Coping T Impression Coping T Impression Coping T Impression Coping Screw T Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Simple Line Ⅱ Fixture Healing Abutment Healing Abutment Healing Abutment Healing Abutmen Healing Abutment Healing Abutment Healing Abutment Healing Abutment Dual Milling Abutment Dual Milling Abutment Dual Milling Abutment Implant Keeper Implant Keeper Implant Keeper Implant Keeper Positioner Abutment Positioner Abutment Positioner Abutment Positioner Abutment Metal-Casting Abutment Metal-Casting Abutment Gold Direct-Casting Gold Direct-Casting Metal-Casting Abutment Metal-Casting Abutment Gold Direct-Casting Gold Direct-Casting Screw Abutment Solid Abutment Solid Abutment Solid Abutment Screw Abutment Solid Abutment Solid Abutment Solid Abutment Burn-out Cylinder Burn-out Cylinder Burn-out Cylinder Burn-out Cylinder Comfort Cap Comfort Cap -Ti Comfort Cap Comfort Cap -Ti Metal-Casting Cylinder Metal-Casting Cylinder Gold Cylinder Metal-Casting Cylinder Metal-Casting Cylinder Gold Cylinder Impression Coping Screw P Impression Coping P Impression Coping P Impression Coping P Reamer Guide Reamer Guide Reamer Guide Reamer Ti-Retaining Screw Ti-Cylinder Ti-Cylinder Ti-Cylinder Ti-Cylinder Impression Coping T Impression Coping T Impression Coping Screw T Plastic Temp. Abutment Plastic Temp. Abutment Ti-Temporary Abutment Ti-Temporary Abutment Plastic Temp. Abutment Plastic Temp. Abutment Ti-Temporary Abutment Ti-Temporary Abutment Adapter - Hand-piece Adapter - Ratchet Adapter - Hand-piece Adapter - Hand-piece Adapter - Ratchet Surgical Kit Mount Adapter - Hand-piece Mount Adapter - Hand-piece Mount Adapter - Hand-piece Path pin Mount Adapter - Ratchet Mount Adapter - Ratchet Mount Adapter - Ratchet Tap Drill Tap Drill Drill Extension Final Drill Guide Drill Final Drill Final Drill Final Drill Final Drill Final Drill Final Drill Hex Driver - Hand-piece Hex Driver – Manual Guide Drill Guide Drill Guide Drill Guide Drill Parallel pin Tap Drill Adapter Ratchet Restorative Kit Restorative Kit Restorative Kit Restorative Kit Restorative Kit Restorative Kit Restorative Kit Restorative Kit Restorative Kit Restorative Kit Tissue Punch
Model Identifier(s)
CRG45L CRG55L CRG65L CRH MFFX483404 MFFX483405 MFFX483406 MFFX483407 MFFX483408 MFFX483804 MFFX483805 MFFX483806 MFFX483807 MFFX483808 MFFX484304 MFFX484305 MFFX484306 MFFX484307 MFFX484308 MFFX484804 MFFX484805 MFFX484806 MFFX484807 MFFX484808 MFFX654304 MFFX654305 MFFX654306 MFFX654307 MFFX654308 MFFX654804 MFFX654805 MFFX654806 MFFX654807 MFFX654808 OISRG 48 OISRM SOAAB4815O SOAAB4825O SOAAB6515O SOAAB6525O SOAAS2023 SOBAB4800 SOBAB6500 SOCAB4808N SOCAB4808O SOCAB4818N SOCAB4818O SOCAB4828N SOCAB4828O SOCAB6508N SOCAB6508O SOCAB6518N SOCAB6518O SOCAB6528N SOCAB6528O SOCAN4840P SOCAN4855P SOCAN4870P SOCAN6540P SOCAN6555P SOCAN6570P SOCS4835 SOCS6543 SODAB4840N SODAB4840O SODAB4855N SODAB4855O SODAB4870N SODAB4870O SODAB6540N SODAB6540O SODAB6555N SODAB6555O SODAB6570N SODAB6570O SODBC48B SODBC48S SODBC65B SODBC65S SODCC4840 SODCC4855 SODCC4870 SODCC6540 SODCC6555 SODCC6570 SODIC48 SODIC65 SODPS11 SODPU4852N SODPU4852O SODPU6568N SODPU6568O SODTF4852N SODTF4852O SODTF6568N SODTF6568O SODTS11 SOFX483408 SOFX483408R SOFX483410 SOFX483410R SOFX483412 SOFX483412R SOFX483414 SOFX483414R SOFX483808 SOFX483808R SOFX483808S SOFX483810 SOFX483810R SOFX483810S SOFX483812 SOFX483812R SOFX483812S SOFX483814 SOFX483814R SOFX483814S SOFX484308 SOFX484308R SOFX484308S SOFX484310 SOFX484310R SOFX484310S SOFX484312 SOFX484312R SOFX484312S SOFX484314 SOFX484314R SOFX484314S SOFX484808 SOFX484808R SOFX484808S SOFX484810 SOFX484810R SOFX484810S SOFX484812 SOFX484812R SOFX484812S SOFX484814 SOFX484814R SOFX484814S SOFX654308 SOFX654308R SOFX654308S SOFX654310 SOFX654310R SOFX654310S SOFX654312 SOFX654312R SOFX654312S SOFX654314 SOFX654314R SOFX654314S SOFX654808 SOFX654808R SOFX654808S SOFX654810 SOFX654810R SOFX654810S SOFX654812 SOFX654812R SOFX654812S SOFX654814 SOFX654814R SOFX654814S SOHAB4810 SOHAB4820 SOHAB4830 SOHAB4840 SOHAB6510 SOHAB6520 SOHAB6530 SOHAB6540 SOMAB4830OG SOMAB6530OG SOMAB7530OG SOMKP4820D SOMKP4840D SOMKP6520D SOMKP6540D SOPAB4800 SOPAB4810 SOPAB6500 SOPAB6510 SORAB4852CN SORAB4852CO SORAB4852N SORAB4852O SORAB6568CN SORAB6568CO SORAB6568N SORAB6568O SOSAB4816 SOSAB4840N SOSAB4855N SOSAB4870N SOSAB6516 SOSAB6540N SOSAB6555N SOSAB6570N SOSBC4816H SOSBC4816N SOSBC6516H SOSBC6516N SOSCC4835 SOSCC48T SOSCC6535 SOSCC65T SOSGC4816CH SOSGC4816CN SOSGC4816H SOSGC6516CH SOSGC6516CN SOSGC6516N SOSPS0916 SOSPU4816H SOSPU4816N SOSPU6516H SOSRG65 SOSRGBL SOSRGSL SOSRM65 SOSRS16T SOSTC4816HG SOSTC4816NG SOSTC6516HG SOSTC6516NG SOSTF4816N SOSTF6516N SOSTS0916 SOTAB4852PN SOTAB4852PO SOTAB4852TNG SOTAB4852TOG SOTAB6568PN SOTAB6568PO SOTAB6568TNG SOTAB6568TOG SOXHD21H SOXHD21W SOXHD24H SOXHD27H SOXHD27W SOXIK SOXMA19 SOXMA22 SOXMA25 SOXMFPAS SOXRA19 SOXRA22 SOXRA25 SOXTD3433 SOXTD3833 XDE XFD3429 XFD3435 XFD3829 XFD3835 XFD4329 XFD4333 XFD4829 XFD4833 XHD25H XHD26T XLD2229 XLD2235 XLD2629 XLD2635 XPP162248 XRA3917 XRCA1 XSSOCAB48 XSSOCAB48S XSSOCAB65 XSSOCAB65S XSSODAB4840 XSSODAB4855 XSSODAB4870 XSSODAB6540 XSSODAB6555 XSSODAB6570 XTS40