FDA 510(k) Applications Submitted by DENTIUM CO., LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K191634 |
06/19/2019 |
Scan Abutments and Comfort Caps |
Dentium Co., Ltd. |
| K192436 |
09/06/2019 |
Healing Abutments and Cover Screws |
Dentium Co., Ltd. |
| K070228 |
01/24/2007 |
IMPLANTIUM PROSTHETICS |
DENTIUM CO., LTD. |
| K060500 |
02/24/2006 |
SPEEDY ORTHODONTIC SCREW |
DENTIUM CO., LTD. |
| K060501 |
02/24/2006 |
IMPLANTIUM II |
DENTIUM CO., LTD. |
| K041368 |
05/24/2004 |
DENTIUM CO., LTD. IMPLANTIUM |
DENTIUM CO., LTD. |
| K052957 |
10/21/2005 |
IMPLANTIUM PROSTHETICS |
DENTIUM CO., LTD. |
| K111162 |
04/25/2011 |
SLIM ONEBODY SYSTEM |
DENTIUM CO., LTD. |
| K102308 |
08/16/2010 |
SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS |
DENTIUM CO., LTD. |
| K213599 |
11/15/2021 |
SuperLine |
Dentium Co., Ltd. |
| K112045 |
07/18/2011 |
SIMPLELINE II ABUTMENT SYSTEM |
DENTIUM CO., LTD. |
| K170384 |
02/07/2017 |
Dentium NR Line CAD/CAM Abutments |
Dentium Co., Ltd. |
| K160828 |
03/25/2016 |
Dentium Implantium & SuperLine Prosthetics |
DENTIUM CO., LTD. |
| K171622 |
06/02/2017 |
Dentium Ti-Base |
Dentium Co., Ltd. |
| K172640 |
09/01/2017 |
Dentium Implantium & SuperLine Prosthetics |
Dentium Co., Ltd. |
| K171126 |
04/17/2017 |
Implantium II |
Dentium Co., Ltd. |
| K160965 |
04/06/2016 |
SuperLine |
DENTIUM CO., LTD. |
| K153268 |
11/12/2015 |
NR Line Implant System |
DENTIUM CO., LTD. |
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