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510(k) K232148

X-Guide Surgical Navigation System by X-Nav Technologies, LLC — Product Code QRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2024
Date Received
July 19, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dental Navigation System
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

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 clearances by X-Nav Technologies, LLC

  • K211701 — X-Guide® Surgical Navigation System (February 1, 2022)
  • K200662 — X-Guide® Surgical Navigation System (May 21, 2020)
  • K192579 — X-Guide Surgical Navigation System (February 3, 2020)
  • K150222 — X-Guide Surgical Navigation System (October 8, 2015)

Other clearances for product code QRY

  • K222750 — Yomi Robotic System (December 8, 2022)
  • K222049 — Yomi Robotic System (November 4, 2022)
  • K211701 — X-Guide® Surgical Navigation System (February 1, 2022)