# K210711: Neocis Guidance System (NGS) with Yomi Plan v2.0.1

- Pathway: 510(k) (Traditional)
- Applicant: Neocis, Inc.
- Decided: Dec 22, 2021 after 287 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: 5 generations back to K983831 (1999). 6 ancestors in all.
5 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)
- K202264: Neocis Guidance System (NGS) with Yomi Plan v2.0, Neocis, Inc. (2020) Summary page 4.

## Most influential descendants
- K222049: Yomi Robotic System (2022), 4 descendants of its own
- 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
The Neocis Guidance System (NGS) is a computerized 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 navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants. When Yomi Plan 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. The output of Yomi Plan is to be used with the Neocis Guidance System (NGS).

Source page: https://510kreport.com/device/K210711
Methodology: https://510kreport.com/methodology