Product code LQZ
- Device name
- Device, Jaw Repositioning
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.5570
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233754 | AIO Breathe | Aiomega, LLC | 2024-02-23 |
| K230532 | RADx Intraoral Appliance for Snoring and Sleep Apnea | Achaemenid, LLC | 2023-07-12 |
| K203712 | The Slide | Biotex, Inc. | 2021-07-20 |
| K191320 | Slow Wave DS8 | Slow Wave, Inc. | 2020-10-02 |
| K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | 2020-01-28 |
| K162816 | SML-OSA2 Appliances | Selane Products, Inc. | 2017-07-27 |
| K130130 | ATG/SM-OSA APPLIANCES | Selane Products, Inc. | 2013-08-26 |
| K112627 | MILLENIUM ANTI-SNORING DEVICE | Millenium Dental Laboratory, Inc. | 2012-06-06 |
| K112766 | SNORKEL | Fellmar Company | 2012-06-04 |
| K113201 | NARVAL CC | Resmed Sas | 2011-12-01 |
| K090911 | IST SNORING APPLIANCE | Dental Crafters | 2009-09-11 |
| K091035 | FULL BREATH SLEEP APPLIANCE LOWER (FBSL) | Bryan Keropian Dds | 2009-06-24 |
| K061228 | FULL BREATH SLEEP APPLIANCE WITH POSTERIOR TONGUE DEPRESSOR | Bryan Keropian Dds | 2006-05-26 |
| K053065 | FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS) | Bryan Keropian Dds | 2006-01-03 |
| K052862 | FULL BREATH SLEEP APPLIANCE - AB (ANTERIOR BITE) | Bryan Keropian Dds | 2005-12-30 |
| K032410 | SNORENTI | James P Boyd | 2005-02-28 |
| K971818 | SNOREX | Snorex (Nz) , Ltd. | 1997-12-18 |
| K960673 | OSAP | Snorefree, Inc. | 1996-05-09 |
| K955503 | ADJUSTABLE PM POSITIONER | Jonathan A. Parker, D.D.S. | 1996-02-08 |
| K953293 | PM POSITIONER | Jonathan A. Parker, D.D.S. | 1995-09-15 |
| K945820 | DESRA | D.S.R.A., Inc. | 1995-06-15 |
| K946112 | ELASTOMERIC SLEEP APPLIANCE | Village Park Orthodontics | 1995-06-14 |
| K932932 | SNOREMASTER SNORE REMEDY | The Snoremaster Co. | 1995-02-10 |
| K922818 | SNORE-NO-MORE | Great Lakes Orthodontics, Ltd. | 1994-02-09 |
| K902790 | NAPA | G-Ortho Lab | 1990-09-19 |
| K880956 | SNOAR(TM) OPEN AIRWAY APPLIANCE | Kent J. Toone, D.D.S. | 1988-05-11 |
| K870501 | THE EQUALIZER AIRWAY DEVICE | Sleep Renewal, Inc. | 1987-03-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850022853036 | ProSomnus RPMO2 OSA Device | PROSOMNUS SLEEP TECHNOLOGIES | 2026-04-24 |
| 00860015650405 | EMA | DENTAL PROSTHETIC SERVICES, INC. | 2026-04-17 |
| 00860008847539 | KAVA HERBST DUAL LAMINATE | APEX DENTAL SLEEP LAB INCORPORATED | 2026-04-14 |
| 00860008847522 | KAVA DORSAL DUAL LAMINATE | APEX DENTAL SLEEP LAB INCORPORATED | 2026-04-14 |
| 00850077473791 | EMA 3D | EMA SLEEP INCORPORATED | 2026-04-14 |
| D775CSAA0 | NAPA Appliance | Great Lakes Dental Technologies, Ltd. | 2026-04-13 |
| 00860008847515 | KAVA HERBST ACRYLIC | APEX DENTAL SLEEP LAB INCORPORATED | 2026-03-18 |
| 00860008847508 | KAVA DORSAL ACRYLIC | APEX DENTAL SLEEP LAB INCORPORATED | 2026-03-18 |
| DR5071026 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DR5044538 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DR5032714 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DR5023119 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DR4032584 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DR3064993 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| 00198168357521 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-03-28 |
| 00850022853029 | ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring | PROSOMNUS SLEEP TECHNOLOGIES | 2024-03-29 |
| 00850022853012 | ProSomnus EVO [PH] Sleep and Snore Device | PROSOMNUS SLEEP TECHNOLOGIES | 2024-03-29 |
| 00863039000485 | ProSomnus EVO Sleep and Snore Device | PROSOMNUS SLEEP TECHNOLOGIES | 2024-03-29 |
| 00863039000492 | ProSomnus EVO Sleep and Snore Device with Patient Monitoring | PROSOMNUS SLEEP TECHNOLOGIES | 2024-03-29 |
| 00810106971445 | Vivos DNA | Aurum Group Ltd | 2023-09-25 |
| 00810106971452 | Vivos mmRNA | Aurum Group Ltd | 2023-09-21 |
| D776OSLEEPV110 | SICAT OPTISLEEP | SiCAT GmbH & Co. KG | 2023-08-03 |
| 00810002220142 | Vivos mmRNA appliance | JOHN'S DENTAL LABORATORY INC | 2023-03-28 |
| 00810002220197 | Vivos DNA | JOHN'S DENTAL LABORATORY INC | 2023-03-13 |
| D776OSLEEPV11 | SICAT OPTISLEEP | SiCAT GmbH & Co. KG | 2022-10-21 |
| 00810002220111 | mmRNA appliance | JOHN'S DENTAL LABORATORY INC | 2022-02-04 |
| D82852000920 | Vivos mmRNA | FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC | 2021-11-19 |
| 00810002220067 | TAP (Thornton Adjustable Positioner) 3 | JOHN'S DENTAL LABORATORY INC | 2020-09-23 |
| 00810002220050 | TAP (Thornton Adjustable Positioner) | JOHN'S DENTAL LABORATORY INC | 2020-09-23 |
| 00810002220036 | EMA (Elastic Mandibular Appliance) | JOHN'S DENTAL LABORATORY INC | 2020-09-23 |