# K220517: IBS System

- Pathway: 510(k) (Traditional)
- Applicant: Innobiosurg Co., Ltd.
- Decided: Dec 20, 2022 after 300 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: 18 generations back to K894595 (1990). 162 ancestors in all.
No later device cites it as a predicate yet.
0 of 163 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212517: Magicore System, Innobiosurg Co., Ltd. (2021) Summary page 4.
- K181138: IS-III active System, Neobiotech Co., Ltd. (2018) Summary page 4.
- K173120: CCM Abutment System, Innobiosurg Co., Ltd. (2018) Summary page 4.
- K200753: IBS Implant System II, Innobiosurg Co., Ltd. (2020) Summary page 4.

## Indications for use
The IBS System is intended to replace missing teeth to restore chewing function. The IBS System 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/K220517
Methodology: https://510kreport.com/methodology