Chrysalis Intelligence · Sponsors · X-Nav Technologies, LLC

X-Nav Technologies, LLC

Lansdale, PA, US · 5 510(k) clearances · 3 recalls

Total clearances
5
2020-02-03 → 2026-08-28
Last 12 months
1
Product codes
2
Most recent
2026-08-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
QRY Dental Navigation System Class II Dental 3 2026-08-28
PLV Dental Stereotaxic Instrument Class II Dental 2 2020-05-21
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
3
Most recent
2024-03-04
DateSeverityStatusRecall # ProductCodeReason
2024-03-04 Class II Ongoing Z-1393-2024 X-Guide Handpiece Adaptor Sleeve 3, Model P010727 — The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto th…
2024-03-04 Class II Ongoing Z-1392-2024 X-Guide Handpiece Adaptor Sleeve 1, Model P010701 — The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto th…
2022-09-28 Class II Ongoing Z-0222-2023 X-Guide X-Mark Probe Tool -used for registering edentulous patients to the software or performing XMark registration. C… — Product missing one of two welds connecting the tip to the shaft, if the remaining weld breaks, it is possible that the tip could fall out during X-Mark registr…
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2026-08-28 K253954 X-Guide Surgical Navigation System QRY Class II Dental
2024-02-21 K232148 X-Guide Surgical Navigation System QRY Class II Dental
2022-02-01 K211701 X-Guide® Surgical Navigation System QRY Class II Dental
2020-05-21 K200662 X-Guide® Surgical Navigation System PLV Class II Dental
2020-02-03 K192579 X-Guide Surgical Navigation System PLV Class II Dental