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MegaGen MiNi Internal Implant System - HSA Registration DE0500859

Access comprehensive regulatory information for MegaGen MiNi Internal 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 DE0500859 and owned by Megagen Implant Co. Ltd.. The device was registered on November 15, 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 C
DE0500859
MegaGen MiNi Internal Implant System
HSA Registration Number: DE0500859
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Product Description

MiNi Internal Implant System is a dental medical device which is implanted into the anterior alveolar bone of the upper or lower jaw bone to support prosthetic device such as dental prosthesis and to restore a chewing function of patient who has defects at the anterior tooth.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0500859
Registration Date
November 15, 2017
Change Notification Approval Date
February 04, 2022
Retention Due Date
November 14, 2025
Product Owner
Short Name
Megagen Implant Co. Ltd.
Address
472, Hanjanggun-ro, Jain-myeon,, Gyeongsan-si, Gyeongsangbuk-do, KOREA, REPUBLIC OF
Registrant
Address
10 UBI CRESCENT, UBI TECHPARK, #04-66, SINGAPORE 408564
Importer
Address
28 KALLANG PLACE, #05-16, SINGAPORE 339158
Model Information
Model Name(s)
Stainless Impression Coping Retentive Cap Insertion Tool Retentive Cap Removal Tool 4 Retentive Caps 4 Retentive Caps 4 Retentive Caps 4 Retentive Caps 4 Retentive Caps 2 Stainless Steel Housings Meg-Rhein Abutment Meg-Rhein Abutment Meg-Rhein Abutment Meg-Rhein Abutment Meg-Rhein Abutment Meg-Rhein Abutment Meg-Rhein Abutment Fuse Abutment Fuse Abutment Fuse Cap Fuse Cap 5 Stainless Steel Housing Angled Abutment Angled Abutment Angled Abutment Angled Abutment Angled Abutment Angled Abutment Abutment Screw Abutment Screw Cover Screw EZ Post Abutment EZ Post Abutment EZ Post Abutment EZ Post Abutment EZ Post Abutment EZ Post Abutment EZ Post Abutment EZ Post Abutment EZ Post Abutment EZ Post Abutment EZ Post Abutment EZ Post Abutment EZ Post Abutment EZ Post Abutment EZ Post Abutment Guide Pin Guide Pin Healing Abutment Healing Abutment Healing Abutment Healing Abutment Healing Abutment Healing Abutment Healing Abutment Healing Abutment Healing Abutment Healing Abutment MiNi Internal Fixture MiNi Internal Fixture MiNi Internal Fixture MiNi Internal Fixture MiNi Internal Fixture MiNi Internal Fixture MiNi Internal Fixture MiNi Internal Fixture MiNi Internal Fixture MiNi Internal Fixture Impression Coping Impression Coping Impression Coping Impression Coping Lab Analog Milling Abutment Milling Abutment Milling Abutment Milling Abutment Milling Abutment Milling Abutment Milling Abutment Milling Abutment Milling Abutment Milling Abutment Milling Abutment Milling Abutment Milling Abutment Milling Abutment Milling Abutment ZrGEN Abutment ZrGEN Abutment Scan Abutment Scan Abutment Temporary Abutment TiGEN Abutment TiGEN Abutment Handpiece Connector Ratchet Connector Plastic Impression Coping Lab Analog 5 Retentive Caps 5 Retentive Caps
Model Identifier(s)
044CAIN 085IAC 091EC 140CEG 140CEN 140CER 140CET 140CEV 141CAE MDR00P MDR01P MDR02P MDR03P MDR04P MDR05P MDR06P MFAA3315P MFAP3535P MFCA15 MFCP MHP MIAA3215ET MIAA3215HT MIAA3315ET MIAA3315HT MIAA3415ET MIAA3415HT MIAS14 MIAZ1410 MICS2505 MIEP3505HT MIEP3507HT MIEP3509HT MIEP3515HT MIEP3517HT MIEP3519HT MIEP3525HT MIEP3527HT MIEP3529HT MIEP3535HT MIEP3537HT MIEP3539HT MIEP3545HT MIEP3547HT MIEP3549HT MIGPP16 MIGPT16 MIHA3025 MIHA3030 MIHA3040 MIHA3050 MIHA3060 MIHA3525 MIHA3530 MIHA3540 MIHA3550 MIHA3560 MIIF3008C MIIF3010C MIIF3011C MIIF3013C MIIF3015C MIIF3308C MIIF3310C MIIF3311C MIIF3313C MIIF3315C MIIP3512HT MIIP3516HT MIIT3512HT MIIT3516HT MILA300H MIMA3005HT MIMA3007HT MIMA3009HT MIMA3015HT MIMA3017HT MIMA3019HT MIMA3025HT MIMA3027HT MIMA3029HT MIMA3035HT MIMA3037HT MIMA3039HT MIMA3045HT MIMA3047HT MIMA3049HT MIPN3013.MTN MIPN3013N.MTN MISS3509T MISS3513T MITA3012HT MITN1020.MTN MITN1020N.MTN OHCS ORCS PIC PLA RCVP RCWP