Sleep Appliances With Patient Monitoring
Dental · 21 CFR 872.5570
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.
Recent MDR events
4 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
14 firms currently registered for this product code
Somnomed, Ltd.
CROWS NEST New South Wales, AU
Braebon Medical Corp.
KANATA Ontario, CA
Somnomed Inc.
Plano, TX, US
Prosomnus Sleep Technologies
Pleasanton, CA, US
Ortho Solutions Lc
Lake Saint Louis, MO, US
Somnomed Phillipines Inc.
Makati City National Capital Region, PH
Gcdl, Llc
Prospect Heights, IL, US
Hexa Ceram Co., Ltd.
Sansai Chiang Mai, TH
510(k) clearances
9 clearances for this product code
- Prosomnus Sleep TechnologiesApr 6, 2026
K252765 · ProSomnus RPMO2 OSA Device (RPMO2 OSA)
- Somnomed, Inc.Oct 3, 2024
K233497 · Rest Assure System
- Residential Home Sleep ServicesApr 10, 2020
K190353 · Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
- Mark Abramson, D.D.S., Inc.Apr 19, 2019
K181571 · OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
- Prosomnous Sleep TechnologiesNov 22, 2017
K172859 · Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
- Gergen'S Orthodontic LabNov 16, 2017
K170606 · Acrylic Herbst Appliance with Micro-Recorder
- Microdental, Inc.Nov 7, 2016
K161624 · MicrO2 OSA Device with Micro-Recorder
- Airway Management, Inc.Aug 10, 2016
K160239 · TAP 3, TAP 1