Cleared Traditional

K253954 - X-Guide Surgical Navigation System

K253954 is an FDA 510(k) clearance for X-Guide Surgical Navigation System, manufactured by X-Nav Technologies, LLC. The device is a Class 2 Dental device with product code QRY cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K253954 · X-Nav Technologies, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2026
Decision
261d
Days
Class 2
Risk

K253954 is an FDA 510(k) clearance for the X-Guide Surgical Navigation System. Classified as Dental Navigation System (product code QRY), Class II - Special Controls.

Submitted by X-Nav Technologies, LLC (Lansdale, US). The FDA issued a Cleared decision on August 28, 2026 after a review of 261 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4120 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all X-Nav Technologies, LLC devices

FDA 510(k) Submission Details - K253954

510(k) Number K253954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2025
Decision Date August 28, 2026
Days to Decision 261 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
134d slower than avg
Panel avg: 127d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QRY Device Classification - Class 2, Special Controls

Product Code QRY Dental Navigation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4120
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.