# K222976: MU System

- Pathway: 510(k) (Traditional)
- Applicant: Dentis Co., Ltd.
- Decided: Jan 12, 2023 after 106 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K894595 (1990). 241 ancestors in all.
No later device cites it as a predicate yet.
0 of 242 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211090: ZENEX Implant System, Izenimplant Co., Ltd. (2022) Summary page 4.

## Indications for use
MU System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of multiple unit restorations including; cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

Source page: https://510kreport.com/device/K222976
Methodology: https://510kreport.com/methodology