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DiaDent Duo-Gun Cordless Backfill Obturation Device - HSA Registration DE0502645

Access comprehensive regulatory information for DiaDent Duo-Gun Cordless 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 DE0502645 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
DE0502645
DiaDent Duo-Gun Cordless Backfill Obturation Device
HSA Registration Number: DE0502645
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Product Description

Duo-Gun is an endodontic device that heat-softens specially-formulated Gutta Percha and enables vertical injection of softened Gutta Percha through the disposable obturation tip into the root canal.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0502645
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)
Gutta Percha Obturator(Medium type, 100ea) Duo-Gun Duo-Gun Handpiece Charger Battery GP Obturation Tip (23G, 4ea) GP Obturation Tip (25G, 4ea) Safety Cap (2ea) Plunger Set Plunger O-Ring Assembly (2ea) Multi Tool (1ea) Scrubbing Brush (1ea) Power Adapter AC Power Cord
Model Identifier(s)
#181-101 #4007-2001 #4007-2010 #4007-2031 #4007-2080 #4007-2120 #4007-2121 #4007-2130 #4007-2140 #4007-2150 #4007-2160 #4007-2161 #4007-2280 #4007-2287