PLC · Sleep Appliances With Patient Monitoring
Dental · 21 CFR 872.5570 · Class 2
Overview
| Product Code | PLC |
|---|---|
| Device Name | Sleep Appliances With Patient Monitoring |
| 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Prosomnus Sleep Technologies | Apr 6, 2026 | SESE |
| K233497 | Rest Assure System | Somnomed, Inc. | Oct 3, 2024 | SESE |
| K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | Residential Home Sleep Services | Apr 10, 2020 | SESE |
| K181571 | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | Mark Abramson, D.D.S., Inc. | Apr 19, 2019 | SESE |
| K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder | Prosomnous Sleep Technologies | Nov 22, 2017 | SESE |
| K170606 | Acrylic Herbst Appliance with Micro-Recorder | Gergen'S Orthodontic Lab | Nov 16, 2017 | SESE |
| K161624 | MicrO2 OSA Device with Micro-Recorder | Microdental, Inc. | Nov 7, 2016 | SESE |
| K160239 | TAP 3, TAP 1 | Airway Management, Inc. | Aug 10, 2016 | SESE |
| 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. | Jun 18, 2015 | SESE |
Top Applicants
- Somnomed, Inc. — 2 clearances
- Airway Management, Inc. — 1 clearance
- Gergen'S Orthodontic Lab — 1 clearance
- Mark Abramson, D.D.S., Inc. — 1 clearance
- Microdental, Inc. — 1 clearance
