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 Jun 27, 2022 as substantially equivalent to K161406 (Claronav, Inc., 2016) after a 454-day review. Its family tree reaches back 4 generations to 1999.
- Decided
- Jun 27, 2022
- Review
- 454 days
- Class
- Class II
- Product code
- PLV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K983831 (1999). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK983831 VECTORVISION2Brainlab AG · 1999
- 3 generations backK023424 Igi-SystemDenx Advanced Dental Systems · 2003
- 2 generations backK150222 X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2015 · Recalled
- 1 generation backK161406 NavidentClaronav, Inc. · 2016
- This deviceK210947 NavidentClaronav, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983831 | VECTORVISION2 | Brainlab AG | 1999 | — |
| −3 | K023424 | Igi-System | Denx Advanced Dental Systems | 2003 | — |
| −2 | K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | 2015 | 1 |
| −1 | K161406 | Navident | Claronav, Inc. | 2016 | — |
| 0 (this device) | K210947 | Navident | Claronav, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K161406 | NavidentSummary page 4…21 CFR 872.4120; Bone Cutting Instrument and Accessories Classification Panel Dental Predicate Devices Primary predicate: ClaroNav’s Navident (K161406) Reference device: X-Nav’s X-Guide (K200662) Indications for Use Navident is a computerized dental navigational system intend… | 2016 |
| † | K200662 | X-Guide® Surgical Navigation System | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 4 companies; a new generation was cleared every 5.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All PLV devicesPLV Dental Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 partially or fully edentulous jaws.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210947 · printed Nov 4, 2026
Cite this page
510(k) Report. “K210947: Navident.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K210947
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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