510(k) clearance

X-Guide Surgical Navigation System

FDA 510(k) source

510(k) number

K253954

Applicant

X-Nav Technologies, LLC

Decision date

Aug 28, 2026

Date received

Dec 10, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

QRY

Device type

Dental Navigation System

Device class

Class II

Regulation

21 CFR 872.4120

Advisory committee

Dental

Statement or summary

Summary

Third party

N

Location

Lansdale, PA, US