# K202100: Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS)

- Pathway: 510(k) (Traditional)
- Applicant: Neocis, Inc.
- Decided: Oct 19, 2020 after 82 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173402: Neocis Guidance System (NGS) with Chairside Splint, Neocis, Inc. (2018) 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.

Source page: https://510kreport.com/device/K202100
Methodology: https://510kreport.com/methodology