# K212517: Magicore System

- Pathway: 510(k) (Special)
- Applicant: Innobiosurg Co., Ltd.
- Decided: Oct 15, 2021 after 66 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: 17 generations back to K894595 (1990). 158 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201981: Magicore System, Innobiosurg Co., Ltd. (2020) Summary page 4.
- K153639: OneQ-SL s-Clean Implant System, Dentis Co., Ltd. (2016) Summary page 4.
- K192197: Magicore II System, Innobiosurg Co., Ltd. (2020) Summary page 4.
- K201621: Magicore II System, Innobiosurg Co., Ltd. (2020) Summary page 4.
- K202418: Magic UCLA Abutment System, Innobiosurg Co., Ltd. (2020) Summary page 4.
- K173120: CCM Abutment System, Innobiosurg Co., Ltd. (2018) Summary page 7.

## Most influential descendants
- K220517: IBS System (2022), 0 descendants of its own

## Indications for use
The Magicore System is intended to replace missing teeth to restore chewing function. The Magicore 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/K212517
Methodology: https://510kreport.com/methodology