# K202479: IBS Implant System

- Pathway: 510(k) (Special)
- Applicant: Innobiosurg Co., Ltd.
- Decided: Sep 23, 2020 after 26 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: 14 generations back to K894595 (1990). 101 ancestors in all.
No later device cites it as a predicate yet.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153350: IBS Implant System, Innobiosurg Co., Ltd. (2016) Summary page 4.
- K140806: Ibs Implant System, Innobiosurg Co., Ltd. (2015) Summary page 4.

## 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 and not for immediate loading. This system is intended for delayed loading.

Source page: https://510kreport.com/device/K202479
Methodology: https://510kreport.com/methodology