Pure Global

Dentium Implant System-Instrument - HSA Registration DE0504828

Access comprehensive regulatory information for Dentium Implant System-Instrument in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504828 and owned by Dentium Co., Ltd. The device was registered on August 18, 2020.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0504828
Dentium Implant System-Instrument
HSA Registration Number: DE0504828
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

Dentium Implant system-Instrument is a device used for dental implant surgery and prosthetic process. Specifically • Drills are bone cutting instruments intended for use to drill or cut into the upper or lower jaw to prepare the surgical site to place an implant. • Adapters/Drivers are used to place the implant or fasten implant and prosthesis.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Dental
Registration Information
Registration Number
DE0504828
Registration Date
August 18, 2020
Retention Due Date
August 17, 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)
Dentium Advanced Sinus Kit Countersink Depth Gauge Stopper Kit Stopper Stopper Stopper Stopper Stopper Stopper Stopper Stopper Stopper Stopper Final Drill Final Drill Final Drill Final Drill Final Drill Final Drill Final Drill Final Drill Fixture Adapter Fixture Adapter Surgical Kit Guide Drill Guide Drill Path Pin Parallel Pin Ratchet Square Driver Square Driver Sinus Bur Kit Drill Extension DASK Drill Fixture Adapter Fixture Adapter Final Drill Final Drill Final Drill Final Drill Final Drill Final Drill Stopper Stopper Stopper Stopper Hex Driver Hex Driver Guide Drill Guide Drill Path Pin Parallel Pin Ratchet DASK Drill DASK Drill DASK Drill DASK Drill Sinus Elevation Instrument Sinus Elevation Instrument Sinus Elevation Instrument Sinus Elevation Instrument Surgical Kit (Short Implant) DASK Drill
Model Identifier(s)
DASK GXCS5029W GXDGL GXDS GXDST05 GXDST05L GXDST07 GXDST07L GXDST09 GXDST09L GXDST11 GXDST11L GXDST13 GXDST13L GXFD3029 GXFD3035 GXFD3629 GXFD3635 GXFD4329 GXFD4335 GXFD5029 GXFD5035 GXID29W GXID30H GXIFK GXLD2229 GXLD2235 GXMFPA GXPP162243 GXRCA GXSD25H GXSD25W SDK XDE XED331035D XFA26W XFA27H XFC3607 XFC4007 XFC4507 XFC5007 XFC6007 XFC7007 XFDST02 XFDST04 XFDST06 XFDST08 XHD25H XHD26T XLD2207 XLD2607 XMFPA2 XPP162212 XRCA1 XRT064025 XRT084025 XRT332035 XRT372035 XSE1L XSE2L XSE3L XSE4L XSIK XST083025