DeviceClearance

Product code QRY— Dental

X-Guide Surgical Navigation System

Classification name
Dental Navigation System
Device class
Class 2
Regulation
21 CFR 872.4120
Advisory panel
Dental
Total cleared
5
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code QRY under 21 CFR 872.4120, via openFDA

Market context for product code QRY

FDA has cleared 5 devices under product code QRY between 2022 and 2026, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QRY

Recent clearances under product code QRY

Data sourced from openFDA. This site is unofficial and independent of the FDA.