# K222049: Yomi Robotic System

- Pathway: 510(k) (Traditional)
- Applicant: Neocis, Inc.
- Decided: Nov 4, 2022 after 115 days
- Product code: QRY (Dental Navigation System)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K983831 (1999). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210711: Neocis Guidance System (NGS) with Yomi Plan v2.0.1, Neocis, Inc. (2021) Summary page 4.

## Most influential descendants
- K222750: Yomi Robotic System (2022), 3 descendants of its own
- K231018: Yomi Robotic System (2023), 2 descendants of its own
- K252376: Yomi S Robotic System (2025), 0 descendants of its own
- K251835: Yomi Robotic System (2025), 0 descendants of its own

## Indications for use
Yomi Robotic System is a computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants. When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan is to be used with the Yomi Robotic System.

Source page: https://510kreport.com/device/K222049
Methodology: https://510kreport.com/methodology