# K203401: Neocis Guidance System (NGS) with Patient Splints (EPS)

- Pathway: 510(k) (Special)
- Applicant: Neocis, Inc.
- Decided: Dec 15, 2020 after 26 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: 4 generations back to K983831 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200805: Neocis Guidance System (NGS) with Patient Splints, Neocis, Inc. (2020) Summary page 4.

## 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/K203401
Methodology: https://510kreport.com/methodology