# K161406: Navident

- Pathway: 510(k) (Traditional)
- Applicant: Claronav, Inc.
- Decided: Sep 8, 2016 after 111 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
- K210947: Navident (2022), 0 descendants of its own

## Indications for use
Navident is a computerized dental navigational system intended to assist preoperative planning and to guide drilling in a patient jaw during implantation surgery, using pre-acquired CT scan of the jaw. The device is intended for use by a qualified dental surgeon in the treatment of partial edentulism.

Source page: https://510kreport.com/device/K161406
Methodology: https://510kreport.com/methodology