510(k) Report

FDA applicant

X-Nav Technologies, LLC

Lansdale, PA6 decisions2015–20264 recalls

FDA records 6 decisions for X-Nav Technologies, LLC (Lansdale, PA) from 2015 to 2026: 6 510(k) clearances. Most are in product codes PLV (Dental Stereotaxic Instrument) and QRY (Dental Navigation System). Since 2016 its 510(k)s took a median of 137 days from receipt to decision, against 86 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 5 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided X-Nav Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2015: 12020: 22022: 12024: 12026 (partial year): 1
2015high 2 (2020) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

2in 2024

2016: 12022: 12024: 2
2015high 2 (2024) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — X-Nav Technologies, LLC by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PLVDental Stereotaxic Instrument3decisions
  • QRYDental Navigation System3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 137 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 86 days; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K150222X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 20156cite it
  • K192579X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 20201cites it
  • K211701X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC · 20221cites it
  • K232148X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 20241cites it

What has FDA decided for it lately?

  • K253954X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2026
  • K232148X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 20242 recalls
  • K211701X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC · 20221 recall
  • K200662X-Guide® Surgical Navigation SystemX-Nav Technologies, LLC · 2020
  • K192579X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 2020
  • K150222X-Guide Surgical Navigation SystemX-Nav Technologies, LLC · 20151 recall

All 6 as X-Nav Technologies, LLC →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K232148X-Guide Handpiece Adaptor Sleeve 1, Model P010701Mar 4, 2024Class II
  • K232148X-Guide Handpiece Adaptor Sleeve 3, Model P010727Mar 4, 2024Class II
  • K211701X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or…Sep 28, 2022Class II
  • K150222X-Guide Surgical Navigation System, X-Clip Bulk Kit The X-Guide Surgical Navigation…Feb 23, 2016Class II