LQZ — Device, Jaw Repositioning Class II
FDA product code LQZ covers "Device, Jaw Repositioning", a Class II medical device regulated under 21 CFR 872.5570. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LQZ
- Device Class
- Class II
- Regulation Number
- 872.5570
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K233754 | aiomega | AIO Breathe | February 23, 2024 |
| K230532 | achaemenid | RADx Intraoral Appliance for Snoring and Sleep Apnea | July 12, 2023 |
| K203712 | biotex | The Slide | July 20, 2021 |
| K191320 | slow wave | Slow Wave DS8 | October 2, 2020 |
| K192581 | advanced facialdontics | The NightBlocks Appliance | January 28, 2020 |
| K162816 | selane products | SML-OSA2 Appliances | July 27, 2017 |
| K130130 | selane products | ATG/SM-OSA APPLIANCES | August 26, 2013 |
| K112627 | millenium dental laboratory | MILLENIUM ANTI-SNORING DEVICE | June 6, 2012 |
| K112766 | fellmar | SNORKEL | June 4, 2012 |
| K113201 | resmed | NARVAL CC | December 1, 2011 |
| K090911 | dental crafters | IST SNORING APPLIANCE | September 11, 2009 |
| K091035 | bryan keropian dds | FULL BREATH SLEEP APPLIANCE LOWER (FBSL) | June 24, 2009 |
| K061228 | bryan keropian dds | FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR | May 26, 2006 |
| K053065 | bryan keropian dds | FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BU | January 3, 2006 |
| K052862 | bryan keropian dds | FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) | December 30, 2005 |
| K032410 | james p boyd | SNORENTI | February 28, 2005 |
| K971818 | snorex (nz) | SNOREX | December 18, 1997 |
| K960673 | snorefree | OSAP | May 9, 1996 |
| K955503 | jonathan a. parker, d.d.s | ADJUSTABLE PM POSITIONER | February 8, 1996 |
| K953293 | jonathan a. parker, d.d.s | PM POSITIONER | September 15, 1995 |