Medical Device Manufacturer · US , Dunwoody , GA

Dentium Co., Ltd. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 2004
22
Total
22
Cleared
0
Denied

Dentium Co., Ltd. has 22 FDA 510(k) cleared dental devices. Based in Dunwoody, US.

Last cleared in 2022. Active since 2004.

Browse the complete list of FDA 510(k) cleared dental devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Mtechgroup and PaxMed International, LLC.

FDA 510(k) Regulatory Record - Dentium Co., Ltd.

22 devices
1-22 of 22
Cleared Feb 23, 2022
SuperLine
K213599 · DZE
Dental · 100d
Cleared Sep 04, 2020
iCTmotor (WL-1)
K193341 · EBW
Dental · 276d
Cleared Jan 23, 2020
Healing Abutments and Cover Screws
K192436 · NHA
Dental · 139d
Cleared Nov 04, 2019
Scan Abutments and Comfort Caps
K191634 · NHA
Dental · 138d
Cleared May 14, 2018
Dentium Implantium & SuperLine Prosthetics
K172640 · NHA
Dental · 255d
Cleared Jan 11, 2018
Dentium Ti-Base
K171622 · NHA
Dental · 223d
Cleared Sep 07, 2017
Implantium II
K171126 · DZE
Dental · 143d
Cleared Aug 17, 2017
Dentium NR Line CAD/CAM Abutments
K170384 · NHA
Dental · 191d
Cleared Jan 13, 2017
SuperLine
K160965 · DZE
Dental · 282d
Cleared Dec 16, 2016
Dentium CAD/CAM Abutments
K161713 · NHA
Dental · 178d
Cleared Sep 15, 2016
Dentium Implantium & SuperLine Prosthetics
K160828 · NHA
Dental · 174d
Cleared Aug 05, 2016
Burn-out Cylinder and Angled Screw Abutments
K160483 · NHA
Dental · 165d
Cleared Jul 20, 2016
NR Line Implant System
K153268 · DZE
Dental · 251d
Cleared Nov 12, 2014
DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS
K141457 · NHA
Dental · 163d
Cleared Jan 26, 2012
SIMPLELINE II ABUTMENT SYSTEM
K112045 · NHA
Dental · 192d
Cleared Jan 13, 2012
SLIM ONEBODY SYSTEM
K111162 · DZE
Dental · 263d
Cleared Nov 22, 2010
SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS
K102308 · DZE
Dental · 98d
Cleared Nov 20, 2007
IMPLANTIUM PROSTHETICS
K070228 · NHA
Dental · 300d
Cleared Jul 27, 2006
IMPLANTIUM PROSTHETICS
K052957 · NHA
Dental · 279d
Cleared Jun 16, 2006
SPEEDY ORTHODONTIC SCREW
K060500 · DZE
Dental · 112d
Cleared Jun 16, 2006
IMPLANTIUM II
K060501 · DZE
Dental · 112d
Cleared Jul 29, 2004
DENTIUM CO., LTD. IMPLANTIUM
K041368 · DZE
Dental · 66d
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