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DiaDent EvoFill Duo Cordless Warm Vertical Compaction & Backfill Obturation Device - HSA Registration DE0502643

Access comprehensive regulatory information for DiaDent EvoFill Duo Cordless Warm Vertical Compaction & Backfill Obturation Device in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0502643 and owned by DiaDent Group International. The device was registered on January 07, 2019.

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
DE0502643
DiaDent EvoFill Duo Cordless Warm Vertical Compaction & Backfill Obturation Device
HSA Registration Number: DE0502643
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Product Description

EvoFill Duo is intended for use by professionally qualified licensed dentists, endodontists and clinicians to heat gutta percha and place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0502643
Registration Date
January 07, 2019
Retention Due Date
January 06, 2026
Product Owner
Short Name
DiaDent Group International
Address
16, Osongsaengmyeong 4-ro,, Osong-eup, Heungdeok-gu Cheongju-si, Chungcheong buk-do,, 28161, KOREA, REPUBLIC OF
Registrant
Address
57 UBI AVENUE 1, UBI CENTRE, #04-01, SINGAPORE 408936
Importer
Address
57 UBI AVENUE 1, UBI CENTRE, #04-01, SINGAPORE 408936
Model Information
Model Name(s)
EvoFill Duo EvoFill™ Duo EvoFill Handpiece EvoFill™ Duo EvoPack Handpiece EvoFill™ Duo Gutta Percha Cartridge(20ea) EvoFill™ Duo Dual Charger EvoFill™ Duo Safety Cap EvoFill™ Duo Battery EvoFill™ Duo Power Adaptor & Cord EvoFill™ Duo, Heating Condenser #XF EvoFill™ Duo, Heating Condenser #F EvoFill™ Duo, Heating Condenser #FM EvoFill™ Duo, Heating Condenser #M EvoFill™ Duo, Heating Condenser #ML EvoFill™ Duo, Heating Condenser #F/FM (1ea each) EvoFill™ Duo, Multi Tool EvoFill™ Duo, Scrubbing Brush
Model Identifier(s)
#4005-1001 #4005-1101 #4005-1201 #4005-2010 #4005-2020 #4005-2030 #4005-2050 #4005-2060 #4005-2070 #4005-2071 #4005-2072 #4005-2073 #4005-2074 #4005-2075 #4005-2080 #4005-2090