QRY · Class II · 21 CFR 872.4120

FDA Product Code QRY: Dental Navigation System

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.

Leading manufacturers include X-Nav Technologies, LLC and Neocis, Inc..

5
Total
5
Cleared
185d
Avg days
2022
Since
Declining activity - 1 submissions in the last 2 years vs 3 in the prior period
Review times increasing: avg 261d recently vs 166d historically

FDA 510(k) Cleared Dental Navigation System Devices (Product Code QRY)

5 devices
1–5 of 5
Cleared Aug 28, 2026
X-Guide Surgical Navigation System
K253954
X-Nav Technologies, LLC
Dental · 261d
Cleared Feb 21, 2024
X-Guide Surgical Navigation System
K232148
X-Nav Technologies, LLC
Dental · 217d
Cleared Dec 08, 2022
Yomi Robotic System
K222750
Neocis, Inc.
Dental · 87d
Cleared Nov 04, 2022
Yomi Robotic System
K222049
Neocis, Inc.
Dental · 115d
Cleared Feb 01, 2022
X-Guide® Surgical Navigation System
K211701
X-Nav Technologies, LLC
Dental · 243d

About Product Code QRY - Regulatory Context

510(k) Submission Activity

5 total 510(k) submissions under product code QRY since 2022, with 5 receiving FDA clearance (average review time: 185 days).

Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - QRY Product Code

Recent submissions under QRY have taken an average of 261 days to reach a decision - up from 166 days historically. Manufacturers should account for longer review timelines in current project planning.

QRY devices are reviewed by the Dental panel. Browse all Dental devices →