# K200805: Neocis Guidance System (NGS) with Patient Splints

- Pathway: 510(k) (Traditional)
- Applicant: Neocis, Inc.
- Decided: Jul 28, 2020 after 123 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: 3 generations back to K983831 (1999). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150222: X-Guide Surgical Navigation System, X-Nav Technologies, LLC (2015) Summary page 4.

## Most influential descendants
- K203401: Neocis Guidance System (NGS) with Patient Splints (EPS) (2020), 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.

Source page: https://510kreport.com/device/K200805
Methodology: https://510kreport.com/methodology