# K231018: Yomi Robotic System

- Pathway: 510(k) (Traditional)
- Applicant: Neocis, Inc.
- Decided: Aug 14, 2023 after 126 days
- Product code: PLV (Dental Stereotaxic Instrument)
- 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: 8 generations back to K983831 (1999). 9 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K222750: Yomi Robotic System, Neocis, Inc. (2022) Summary page 4.

## Most influential descendants
- 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 Robotic System 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. YomiPlan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of YomiPlan is to be used with the Yomi Robotic System.

Source page: https://510kreport.com/device/K231018
Methodology: https://510kreport.com/methodology