Atlas FDA

LQZ

27 FDA 510(k) clearances · Product code

135 daysmedian time to decision
574 days90th percentile
27clearances measured

FDA profile

Official device name
Device, Jaw Repositioning
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5570
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
2000: 2 · 2004: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
AIO Breathe (K233754)Aiomega, LLC2024-02-23
RADx Intraoral Appliance for Snoring and Sleep Apnea (K230532)Achaemenid, LLC2023-07-12
The Slide (K203712)Biotex, Inc.2021-07-20
Slow Wave DS8 (K191320)Slow Wave, Inc.2020-10-02
The NightBlocks Appliance (K192581)Advanced Facialdontics, LLC2020-01-28
SML-OSA2 Appliances (K162816)Selane Products, Inc.2017-07-27
ATG/SM-OSA APPLIANCES (K130130)Selane Products, Inc.2013-08-26
MILLENIUM ANTI-SNORING DEVICE (K112627)Millenium Dental Laboratory, Inc.2012-06-06
SNORKEL (K112766)Fellmar Company2012-06-04
NARVAL CC (K113201)Resmed Sas2011-12-01
IST SNORING APPLIANCE (K090911)Dental Crafters2009-09-11
FULL BREATH SLEEP APPLIANCE LOWER (FBSL) (K091035)Bryan Keropian Dds2009-06-24
FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR (K061228)Bryan Keropian Dds2006-05-26
FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) (K053065)Bryan Keropian Dds2006-01-03
FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) (K052862)Bryan Keropian Dds2005-12-30
SNORENTI (K032410)James P Boyd2005-02-28
SNOREX (K971818)Snorex (Nz) , Ltd.1997-12-18
OSAP (K960673)Snorefree, Inc.1996-05-09
ADJUSTABLE PM POSITIONER (K955503)Jonathan A. Parker, D.D.S.1996-02-08
PM POSITIONER (K953293)Jonathan A. Parker, D.D.S.1995-09-15
DESRA (K945820)D.S.R.A., Inc.1995-06-15
ELASTOMERIC SLEEP APPLIANCE (K946112)Village Park Orthodontics1995-06-14
SNOREMASTER SNORE REMEDY (K932932)The Snoremaster Co.1995-02-10
SNORE-NO-MORE (K922818)Great Lakes Orthodontics, Ltd.1994-02-09
NAPA (K902790)G-Ortho Lab1990-09-19
SNOAR(TM) OPEN AIRWAY APPLIANCE (K880956)Kent J. Toone, D.D.S.1988-05-11
THE EQUALIZER AIRWAY DEVICE (K870501)Sleep Renewal, Inc.1987-03-04

Track LQZ automatically

Every clearance here is in the API, with alerts when new ones post.