Sleep Appliances With Patient Monitoring
Regulation 872.5570
2510(k)s in 12 months (10 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in PLC
| Company | 510(k)s | Recalls |
|---|---|---|
| Somnomed, Inc. | 2 | 0 |
| Achaemenid, LLC | 1 | 0 |
| Airway Management, Inc. | 1 | 0 |
| Gergen'S Orthodontic Lab | 1 | 0 |
| Mark Abramson, D.D.S., Inc. | 1 | 0 |
| Microdental, Inc. | 1 | 0 |
| Prosomnous Sleep Technologies | 1 | 0 |
| Prosomnus Sleep Technologies | 1 | 0 |
| Residential Home Sleep Services | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 25, 2026 | K254304 | iNOS intraoral biosensor Achaemenid, LLC | PLC |
| Apr 6, 2026 | K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) Prosomnus Sleep Technologies | PLC |
| Oct 3, 2024 | K233497 | Rest Assure System Somnomed, Inc. | PLC |
| Apr 10, 2020 | K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac Residential Home Sleep Services | PLC |
| Apr 19, 2019 | K181571 | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor Mark Abramson, D.D.S., Inc. | PLC |
| Nov 22, 2017 | K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder Prosomnous Sleep Technologies | PLC |
| Nov 16, 2017 | K170606 | Acrylic Herbst Appliance with Micro-Recorder Gergen'S Orthodontic Lab | PLC |
| Nov 7, 2016 | K161624 | MicrO2 OSA Device with Micro-Recorder Microdental, Inc. | PLC |
| Aug 10, 2016 | K160239 | TAP 3, TAP 1 Airway Management, Inc. | PLC |
| Jun 18, 2015 | K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance Somnomed, Inc. | PLC |
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