LQZ · Class II · 21 CFR 872.5570

FDA Product Code LQZ: Device, Jaw Repositioning

Leading manufacturers include Bryan Keropian Dds, Selane Products, Inc. and Millenium Dental Laboratory, Inc..

Total

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

RADx Intraoral Appliance for Snoring and Sleep Apnea

The NightBlocks Appliance

K192581

Advanced Facialdontics, LLC

Selane Products, Inc.

Dental · 294d

Cleared Aug 26, 2013

ATG/SM-OSA APPLIANCES

K130130

Selane Products, Inc.

Dental · 221d

Cleared Jun 06, 2012

MILLENIUM ANTI-SNORING DEVICE

K112627

Millenium Dental Laboratory, Inc.

IST SNORING APPLIANCE

FULL BREATH SLEEP APPLIANCE LOWER (FBSL)

FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR

FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)

FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)

ADJUSTABLE PM POSITIONER

K955503

Jonathan A. Parker, D.D.S.

Dental · 69d

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.

FDA Product Code LQZ: Device, Jaw Repositioning

FDA 510(k) Cleared Device, Jaw Repositioning Devices (Product Code LQZ)

About Product Code LQZ - Regulatory Context

510(k) Submission Activity

Related FDA 510(k) Regulatory Insights