# K173402: Neocis Guidance System (NGS) with Chairside Splint

- Pathway: 510(k) (Traditional)
- Applicant: Neocis, Inc.
- Decided: Feb 22, 2018 after 114 days
- Product code: PLV (Dental Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 872.4120
- Recalls of this device: 4 (0 Class I)
- 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.
5 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161399: Neocis Guidance System, Neocis, Inc. (2016) Summary page 4.

## Most influential descendants
- K182776: Neocis Guidance System (2018), 2 descendants of its own
- K202100: Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) (2020), 0 descendants of its own
- K200348: Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) (2020), 0 descendants of its own
- K191363: Neocis Planning Software Application (NPSA) for 3rd Party PCs (2019), 0 descendants of its own
- K191605: Neocis Guidance System (NGS) (2019), 0 descendants of its own

## Recalls of this device
- Oct 30, 2020 · Class II · Z-0929-2021: The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.
- May 14, 2020 · Class II · Z-2639-2020: The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
- May 14, 2020 · Class II · Z-2638-2020: The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
- May 14, 2020 · Class II · Z-2637-2020: The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.

## 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/K173402
Methodology: https://510kreport.com/methodology