Singapore HSA registration DE0502642
DiaDent Dia-Duo Cordless Warm Vertical Compaction & Backfill Obturation Device
Singapore·CLASS B·DiaDent Group International·Registered January 07, 2019Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Dental
Registration information
- Registration Number
- DE0502642
- Registration Date
- January 07, 2019
- Retention Due Date
- January 06, 2026
Product description
Dia-Duo is a cordless obturation system that includes Duo-Pen warm vertical compaction device and Duo-Gun backfill obturation device. Duo-Pen is an endodontic device that uses heat to cut, soften, downpack, and compact the root canal filling material (gutta percha obturators or gutta percha points). 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.
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) Dia-Duo Duo-Gun Handpiece Duo-Pen Handpiece Duo Charger Heating Condenser(.04-50) Heating Condenser(.06-50) Battery Battery GP Obturation Tip (23G, 4ea) Safety Cap (2ea) Plunger Set Plunger O-Ring Assembly (2ea) Multi Tool (1ea) Scrubbing Brush (1ea) Disposable Sheath(200ea/box) Power Adapter AC Power Cord
- Model Identifier(s)
- #181-101 #4007-2000 #4007-2010 #4007-2020 #4007-2030 #4007-2072 #4007-2073 #4007-2080 #4007-2090 #4007-2120 #4007-2130 #4007-2140 #4007-2150 #4007-2160 #4007-2161 #4007-2270 #4007-2280 #4007-2287
About this record
Access comprehensive regulatory information for DiaDent Dia-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 DE0502642 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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