510(k) · Cleared
ClearedNavident
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Claronav, Inc. · PLV Dental Stereotaxic Instrument
Cleared on Sep 8, 2016 as substantially equivalent to K150222 (X-Nav Technologies, LLC, 2015) after a 111-day review. Its family tree reaches back 3 generations to 1999. 1 later device descends from it.
- Decided
- Sep 8, 2016
- Review
- 111 days
- Class
- Class II
- Product code
- PLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K983831 (1999). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 2 generations backK023424 Igi-SystemDenx Advanced Dental Systems · 2003
- 1 generation backK150222 X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2015 · Recalled
- This deviceK161406 NavidentClaronav, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK210947 NavidentClaronav, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K210947NavidentClaronav, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −2 | K023424 | Igi-System | Denx Advanced Dental Systems | 2003 | — |
| −1 | K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2015 | 1 |
| 0 (this device) | K161406 | Navident | Claronav, Inc. | 2016 | — |
| +1 | K210947 | Navident | Claronav, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PLV? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PLV device
- #1 K231018 Yomi Robotic Systemscore 13.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150222 | X-Guide Surgical Navigation SystemSummary page 4…t and Accessories Classification Regulation #: CFR 872.4120 Classification Panel: Dental Predicate Devices: X-Guide Surgical Navigation System (k150222) DEVICE DESCRIPTION Navident is a cart-based, computerized, image-guided dental navigational system, operating as a combined pa… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210947 | Navident | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K210947 (Claronav, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K150222.
How does its category compare?
All PLV devicesPLV Dental Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PLV
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLV
399in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLV
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PLV
6in 2025
MAUDE reports naming product code PLV, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 1 | 3 |
| 2020 | 7 | 86 | 1 | 0 |
| 2021 | 2 | — | 0 | 11 |
| 2022 | 3 | 399 | 0 | 39 |
| 2023 | 1 | — | 0 | 15 |
| 2024 | 1 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161406 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161406: Navident.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161406
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026