Product Code: LQZ FDA class 2 21 CFR 872.5570

Device, Jaw Repositioning

Dental

The Jaw Repositioning Device is a dental appliance used to reposition the mandible or alter the occlusal relationship of the jaws, which may be employed for the management of temporomandibular disorders (TMD) or as an anti-snoring aid, depending on the specific device design. It is classified as a Class 2 (moderate risk) device, subject to general and special controls, and requires 510(k) premarket notification before marketing. The product code is LQZ, regulated under 21 CFR 872.5570, within the Dental medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LQZ
Device Class: FDA class 2
Regulation Number: 872.5570
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K233754	AIO Breathe	Feb 23, 2024	Substantially Equivalent	Aiomega, LLC
K230532	RADx Intraoral Appliance for Snoring and Sleep Apnea	Jul 12, 2023	Substantially Equivalent	Achaemenid, LLC
K203712	The Slide	Jul 20, 2021	Substantially Equivalent	Biotex, Inc.
K191320	Slow Wave DS8	Oct 02, 2020	Substantially Equivalent	Slow Wave, Inc.
K192581	The NightBlocks Appliance	Jan 28, 2020	Substantially Equivalent	Advanced Facialdontics, LLC
K162816	SML-OSA2 Appliances	Jul 27, 2017	Substantially Equivalent	Selane Products, Inc.
K130130	ATG/SM-OSA APPLIANCES	Aug 26, 2013	Substantially Equivalent	Selane Products, Inc.
K112627	MILLENIUM ANTI-SNORING DEVICE	Jun 06, 2012	Substantially Equivalent	Millenium Dental Laboratory, Inc.
K112766	SNORKEL	Jun 04, 2012	Substantially Equivalent	Fellmar Company
K113201	NARVAL CC	Dec 01, 2011	Substantially Equivalent	Resmed Sas
K090911	IST SNORING APPLIANCE	Sep 11, 2009	Substantially Equivalent	Dental Crafters
K091035	FULL BREATH SLEEP APPLIANCE LOWER (FBSL)	Jun 24, 2009	Substantially Equivalent	Bryan Keropian Dds
K061228	FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR	May 26, 2006	Substantially Equivalent	Bryan Keropian Dds
K053065	FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)	Jan 03, 2006	Substantially Equivalent	Bryan Keropian Dds
K052862	FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE)	Dec 30, 2005	Substantially Equivalent	Bryan Keropian Dds
K032410	SNORENTI	Feb 28, 2005	Substantially Equivalent	James P Boyd
K971818	SNOREX	Dec 18, 1997	Substantially Equivalent	Snorex (Nz) , Ltd.
K960673	OSAP	May 09, 1996	Substantially Equivalent	Snorefree, Inc.
K955503	ADJUSTABLE PM POSITIONER	Feb 08, 1996	Substantially Equivalent	Jonathan A. Parker, D.D.S.
K953293	PM POSITIONER	Sep 15, 1995	Substantially Equivalent	Jonathan A. Parker, D.D.S.
K945820	DESRA	Jun 15, 1995	Substantially Equivalent	D.S.R.A., Inc.
K946112	ELASTOMERIC SLEEP APPLIANCE	Jun 14, 1995	Substantially Equivalent	Village Park Orthodontics
K932932	SNOREMASTER SNORE REMEDY	Feb 10, 1995	Substantially Equivalent	The Snoremaster Co.
K922818	SNORE-NO-MORE	Feb 09, 1994	Substantially Equivalent	Great Lakes Orthodontics, Ltd.
K902790	NAPA	Sep 19, 1990	Substantially Equivalent	G-Ortho Lab
K880956	SNOAR(TM) OPEN AIRWAY APPLIANCE	May 11, 1988	Substantially Equivalent	Kent J. Toone, D.D.S.
K870501	THE EQUALIZER AIRWAY DEVICE	Mar 04, 1987	Substantially Equivalent	Sleep Renewal, Inc.