Therapeutic devices · 21 CFR 872 Subpart F
Sleep Appliances with Patient Monitoring
For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy.
- Companies listing it
- 66 makers
- Brands and models
- 20
- 510(k) clearances
- 103 in five years
- FDA name
- Sleep Appliances With Patient Monitoring
510(k) clearances per year, 1976–2026
Companies that list PLC
6 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Somnomed, Inc. | United States | Maker | DentiTrac · SomnoDent AVANT | 11 | 2026 |
| ProSomnus Sleep Technologies | United States | Maker | MicrO2 Sleep Device with MicroRecorder · Prosomnus [CA] Low Profile Sleep and snore Device with Compliance Monitoring · Prosomnus [IA] Sleep Device with MicroRecorder · Prosomnus [PH] Sleep and Snore Device · +6 | 3 | 2026 |
| Ortho Solutions LC | United States | Maker | Respire Pink DeniTrac® Hard; Respire Pink DeniTrac® Hard/Soft | — | — |
| Shenzhen Osmiler Intelligent Technology Co., Ltd. | China | Maker | Device, anti-snoring · Device, jaw repositioning · Medical device data system · Oximeter · +1 | — | — |
| Hexa Ceram Co., Ltd. | Thailand | Maker | Pink Series with DentiTrac | — | — |
| GCDL, LLC | United States | Maker | Tap 3 Tap 1 | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 25 Aug 2026 | K254304 | iNOS intraoral biosensor | Achaemenid, LLC |
| 6 Apr 2026 | K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | ProSomnus Sleep Technologies |
| 3 Oct 2024 | K233497 | Rest Assure System | Somnomed, Inc. |
| 10 Apr 2020 | K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | Residential Home Sleep Services |
| 19 Apr 2019 | K181571 | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | Mark Abramson, D.D.S., Inc. |
| 22 Nov 2017 | K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder | Prosomnous Sleep Technologies |
| 16 Nov 2017 | K170606 | Acrylic Herbst Appliance with Micro-Recorder | Gergens Orthodontic Lab |
| 7 Nov 2016 | K161624 | MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. |
| 10 Aug 2016 | K160239 | TAP 3, TAP 1 | Airway Management, Inc. |
| 18 Jun 2015 | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder | Somnomed, Inc. |
Official records: FDA product classification for PLC · 21 CFR 872.5570.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026