X-Guide Surgical Navigation System

FDA 510(k) K253954 · X-Nav Technologies, LLC

Substantially Equivalent

510(k) numberK253954

Submission

Device name
X-Guide Surgical Navigation System
Applicant
X-Nav Technologies, LLC
Lansdale, PA, US
Received
December 10, 2025
Decision date
August 28, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
QRY – Dental Navigation System
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4120
Specialty
Dental

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.

Other 510(k)s with product code QRY

510(k)DeviceApplicantDecision
K232148X-Guide Surgical Navigation SystemQRY · Traditional X-Nav Technologies, LLC02/21/2024SE
K222750Yomi Robotic SystemQRY · Traditional Neocis, Inc.12/08/2022SE
K222049Yomi Robotic SystemQRY · Traditional Neocis, Inc.11/04/2022SE
K211701X-Guide® Surgical Navigation SystemQRY · Traditional X-Nav Technologies, LLC02/01/2022SE

More from X-Nav Technologies, LLC

510(k)DeviceDecision
K232148X-Guide Surgical Navigation SystemQRY · Traditional 02/21/2024SE
K211701X-Guide® Surgical Navigation SystemQRY · Traditional 02/01/2022SE
K200662X-Guide® Surgical Navigation SystemPLV · Special 05/21/2020SE
K192579X-Guide Surgical Navigation SystemPLV · Traditional 02/03/2020SE
K150222X-Guide Surgical Navigation SystemPLV · Traditional 10/08/2015SE

Questions and answers

When was X-Guide Surgical Navigation System cleared by the FDA?

X-Guide Surgical Navigation System (K253954) received a 510(k) decision of Substantially Equivalent on August 28, 2026, 261 days after the submission was received.

What is the product code of K253954?

The FDA product code is QRY – Dental Navigation System, a Class II (moderate risk) device regulated under 21 CFR 872.4120.