FDA Product Code LQZ: Device, Jaw Repositioning
Leading manufacturers include Biotex, Inc., Achaemenid, LLC and Aiomega, LLC.
27
Total
27
Cleared
197d
Avg days
1987
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Device, Jaw Repositioning Devices (Product Code LQZ)
27 devices
Cleared
Feb 23, 2024
AIO Breathe
Aiomega, LLC
Dental
93d
Cleared
Jul 12, 2023
RADx Intraoral Appliance for Snoring and Sleep Apnea
Achaemenid, LLC
Dental
135d
Cleared
Jul 20, 2021
The Slide
Biotex, Inc.
Dental
211d
About Product Code LQZ - Regulatory Context
510(k) Submission Activity
27 total 510(k) submissions under product code LQZ since 1987, with 27 receiving FDA clearance (average review time: 197 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
LQZ devices are reviewed by the Dental panel. Browse all Dental devices →