510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253954Substantially Equivalent

X-Guide Surgical Navigation System

X-Nav Technologies, LLC, Lansdale PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253954 is the FDA 510(k) clearance record for X-Guide Surgical Navigation System, a class II device, cleared for X-Nav Technologies, LLC on under FDA product code QRY (Dental Navigation System). FDA's definition for product code QRY reads: "Intended to provide real-time guidance on the orientation and location of the dental instrument relative to the patient's anatomy for general dentistry procedures". As of , FDA records show no recalls naming K253954.

Clearance record

Decision date
Received
(261 days to decision)
Product code
QRY Dental Navigation System
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
X-Nav Technologies, LLC 1555 Bustard Rd., Lansdale PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QRY

Trailing 12 months
1 clearance under product code QRY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QRY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260