LQZ · Device, Jaw Repositioning
Dental · 21 CFR 872.5570 · Class 2
Overview
| Product Code | LQZ |
|---|---|
| Device Name | Device, Jaw Repositioning |
| Regulation | 21 CFR 872.5570 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.
Classification Rationale
Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
Special Controls
*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K233754 | AIO Breathe | Aiomega, LLC | Feb 23, 2024 | SESE |
| K230532 | RADx Intraoral Appliance for Snoring and Sleep Apnea | Achaemenid, LLC | Jul 12, 2023 | SESE |
| K203712 | The Slide | Biotex, Inc. | Jul 20, 2021 | SESE |
| K191320 | Slow Wave DS8 | Slow Wave, Inc. | Oct 2, 2020 | SESE |
| K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | Jan 28, 2020 | SESE |
| K162816 | SML-OSA2 Appliances | Selane Products, Inc. | Jul 27, 2017 | SESE |
| K130130 | ATG/SM-OSA APPLIANCES | Selane Products, Inc. | Aug 26, 2013 | SESE |
| K112627 | MILLENIUM ANTI-SNORING DEVICE | Millenium Dental Laboratory, Inc. | Jun 6, 2012 | SESE |
| K112766 | SNORKEL | Fellmar Company | Jun 4, 2012 | SESE |
| K113201 | NARVAL CC | Resmed Sas | Dec 1, 2011 | SESE |
| K090911 | IST SNORING APPLIANCE | Dental Crafters | Sep 11, 2009 | SESE |
| K091035 | FULL BREATH SLEEP APPLIANCE LOWER (FBSL) | Bryan Keropian Dds | Jun 24, 2009 | SESE |
| K061228 | FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR | Bryan Keropian Dds | May 26, 2006 | SESE |
| K053065 | FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) | Bryan Keropian Dds | Jan 3, 2006 | SESE |
| K052862 | FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) | Bryan Keropian Dds | Dec 30, 2005 | SESE |
| K032410 | SNORENTI | James P Boyd | Feb 28, 2005 | SESE |
| K971818 | SNOREX | Snorex (Nz) , Ltd. | Dec 18, 1997 | SESE |
| K960673 | OSAP | Snorefree, Inc. | May 9, 1996 | SESE |
| K955503 | ADJUSTABLE PM POSITIONER | Jonathan A. Parker, D.D.S. | Feb 8, 1996 | SESE |
| K953293 | PM POSITIONER | Jonathan A. Parker, D.D.S. | Sep 15, 1995 | SESE |
Top Applicants
- Bryan Keropian Dds — 4 clearances
- Jonathan A. Parker, D.D.S. — 2 clearances
- Selane Products, Inc. — 2 clearances
- Achaemenid, LLC — 1 clearance
- Advanced Facialdontics, LLC — 1 clearance
