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..
4
Total
4
Cleared
166d
Avg days
2022
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared Dental Navigation System Devices (Product Code QRY)
4 devices
Cleared
Feb 21, 2024
X-Guide Surgical Navigation System
X-Nav Technologies, LLC
Dental
217d
Cleared
Dec 08, 2022
Yomi Robotic System
Neocis, Inc.
Dental
87d
Cleared
Nov 04, 2022
Yomi Robotic System
Neocis, Inc.
Dental
115d
Cleared
Feb 01, 2022
X-Guide® Surgical Navigation System
X-Nav Technologies, LLC
Dental
243d
About Product Code QRY - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QRY since 2022, with 4 receiving FDA clearance (average review time: 166 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.
QRY devices are reviewed by the Dental panel. Browse all Dental devices →