# K153350: IBS Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Innobiosurg Co., Ltd.
- Decided: May 9, 2016 after 171 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894595 (1990). 100 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 108 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140806: Ibs Implant System, Innobiosurg Co., Ltd. (2015) Summary page 6.
- K140507: Hiossen Prosthetic System, Osstem Implant Co., Ltd. (2014) Summary page 7.
- K123755: Multi Angled Abutment, Osstem Implant Co., Ltd. (2013) Summary page 7.
- K111120: CSM Submerged-R Implant System, Csm Implant (2011) Summary page 7.

## Most influential descendants
- K162099: IBS Implant System II (2017), 5 descendants of its own
- K173120: CCM Abutment System (2018), 3 descendants of its own
- K202418: Magic UCLA Abutment System (2020), 2 descendants of its own
- K212517: Magicore System (2021), 1 descendant of its own
- K200753: IBS Implant System II (2020), 1 descendant of its own

## Indications for use
The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant can be placed in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations, and terminal or immediate abutment support for fixed bridgework. This system is for one or two stage surgical procedures. This system is intended for delayed loading.

Source page: https://510kreport.com/device/K153350
Methodology: https://510kreport.com/methodology