LQZ · Class II · 21 CFR 872.5570

FDA Product Code LQZ: Device, Jaw Repositioning

Leading manufacturers include Slow Wave, Inc., Advanced Facialdontics, LLC and Biotex, Inc..

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
1–24 of 27
Cleared Feb 23, 2024
AIO Breathe
K233754
Aiomega, LLC
Dental · 93d
Cleared Jul 12, 2023
RADx Intraoral Appliance for Snoring and Sleep Apnea
K230532
Achaemenid, LLC
Dental · 135d
Cleared Jul 20, 2021
The Slide
K203712
Biotex, Inc.
Dental · 211d
Cleared Oct 02, 2020
Slow Wave DS8
K191320
Slow Wave, Inc.
Dental · 506d
Cleared Jan 28, 2020
The NightBlocks Appliance
K192581
Advanced Facialdontics, LLC
Dental · 131d

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.