FDA-Cleared Jaw Repositioning Devices (Product Code LQZ): All 27 510(k)s

FDA groups devices by product code. Code LQZ is "Device, Jaw Repositioning" (FDA classification record). The most recent clearance is K233754 ("AIO Breathe", February 23, 2024); the oldest is K870501 (March 4, 1987).

Brand pages for this product code

ResMed Narval CC

All 27 records, newest first

FDA 510(k) records under product code LQZ
510(k) number	Device name (as filed)	Applicant	Decision date	Product code	Decision
K233754	AIO Breathe	Aiomega, LLCTyler, TX	February 23, 2024	LQZ	Substantially Equivalent
K230532	RADx Intraoral Appliance for Snoring and Sleep Apnea	Achaemenid, LLCStratford, CT	July 12, 2023	LQZ	Substantially Equivalent
K203712	The Slide	Biotex, Inc.Houston, TX	July 20, 2021	LQZ	Substantially Equivalent
K191320	Slow Wave DS8	Slow Wave, Inc.Spicewood, TX	October 2, 2020	LQZ	Substantially Equivalent
K192581	The NightBlocks Appliance	Advanced Facialdontics, LLCSt James, NY	January 28, 2020	LQZ	Substantially Equivalent
K162816	SML-OSA2 Appliances	Selane Products, Inc.Chatsworth, CA	July 27, 2017	LQZ	Substantially Equivalent
K130130	ATG/SM-OSA APPLIANCES	Selane Products, Inc.Bradenton, FL	August 26, 2013	LQZ	Substantially Equivalent
K112627	MILLENIUM ANTI-SNORING DEVICE	Millenium Dental Laboratory, Inc.Ramsey, MN	June 6, 2012	LQZ	Substantially Equivalent
K112766	SNORKEL	Fellmar CompanyMonrovia, CA	June 4, 2012	LQZ	Substantially Equivalent
K113201	NARVAL CC	Resmed SasSan Diego, CA	December 1, 2011	LQZ	Substantially Equivalent
K090911	IST SNORING APPLIANCE	Dental CraftersMarshfeld, WI	September 11, 2009	LQZ	Substantially Equivalent
K091035	FULL BREATH SLEEP APPLIANCE LOWER (FBSL)	Bryan Keropian DdsTarzana, CA	June 24, 2009	LQZ	Substantially Equivalent
K061228	FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR	Bryan Keropian DdsTarzana, CA	May 26, 2006	LQZ	Substantially Equivalent
K053065	FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)	Bryan Keropian DdsTarzana, CA	January 3, 2006	LQZ	Substantially Equivalent
K052862	FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)	Bryan Keropian DdsTarzana, CA	December 30, 2005	LQZ	Substantially Equivalent
K032410	SNORENTI	James P BoydSolana Beach, CA	February 28, 2005	LQZ	Substantially Equivalent
K971818	SNOREX	Snorex (Nz) , Ltd.Springfield, VA	December 18, 1997	LQZ	Substantially Equivalent
K960673	OSAP	Snorefree, Inc.East Islip, NY	May 9, 1996	LQZ	Substantially Equivalent
K955503	ADJUSTABLE PM POSITIONER	Jonathan A. Parker, D.D.S.Washington, DC	February 8, 1996	LQZ	Substantially Equivalent
K953293	PM POSITIONER	Jonathan A. Parker, D.D.S.Washington, DC	September 15, 1995	LQZ	Substantially Equivalent
K945820	DESRA	D.S.R.A., Inc.East Lansing, MI	June 15, 1995	LQZ	Substantially Equivalent
K946112	ELASTOMERIC SLEEP APPLIANCE	Village Park OrthodonticsDepew, NY	June 14, 1995	LQZ	Substantially Equivalent
K932932	SNOREMASTER SNORE REMEDY	The Snoremaster Co.Philadelphia, PA	February 10, 1995	LQZ	Substantially Equivalent
K922818	SNORE-NO-MORE	Great Lakes Orthodontics, Ltd.Tonawanda, NY	February 9, 1994	LQZ	Substantially Equivalent
K902790	NAPA	G-Ortho LabHonolulu, HI	September 19, 1990	LQZ	Substantially Equivalent
K880956	SNOAR(TM) OPEN AIRWAY APPLIANCE	Kent J. Toone, D.D.S.Cupertino, CA	May 11, 1988	LQZ	Substantially Equivalent
K870501	THE EQUALIZER AIRWAY DEVICE	Sleep Renewal, Inc.Mobile, AL	March 4, 1987	LQZ	Substantially Equivalent

What this page is, and what it is not

This is a copy of public FDA records, not a review. 40 Winks has not tested these devices for this page.
A 510(k) clearance means FDA found a device substantially equivalent to a device already legally on the market. It is not an FDA approval, it is not an endorsement by FDA or by 40 Winks, and it does not show that a device will work for you. FDA's own rule (21 CFR 807.97) says a 510(k) clearance does not mean FDA has approved the device.
A clearance covers the specific device and model in the filing. Check that the product you are buying matches the 510(k) number and name, and read the intended use in FDA's record.
Loud, regular snoring can be a sign of obstructive sleep apnea. Talk to a doctor or a dentist trained in sleep medicine before relying on a mouthpiece, and ask whether a sleep test makes sense.

How to check a clearance yourself

Open FDA's 510(k) Premarket Notification database.
Search by the 510(k) number (it starts with K) or by the device or company name.
Open the record and read the device name, applicant, decision date and the linked summary or statement, which describes the intended use.
If a seller says "FDA approved" or "FDA cleared" but gives no 510(k) number, ask for it.

Search every record by name, company or K-number in the FDA clearance lookup.