# K210947: Navident

- Pathway: 510(k) (Traditional)
- Applicant: Claronav, Inc.
- Decided: Jun 27, 2022 after 454 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)
- K161406: Navident, Claronav, Inc. (2016) Summary page 4.

## 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 partially or fully edentulous jaws.

Source page: https://510kreport.com/device/K210947
Methodology: https://510kreport.com/methodology