PLC — Sleep Appliances With Patient Monitoring Class II
FDA product code PLC covers "Sleep Appliances With Patient Monitoring", a Class II medical device regulated under 21 CFR 872.5570. Submissions are reviewed by the Dental panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PLC
- Device Class
- Class II
- Regulation Number
- 872.5570
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Definition
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 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252765 | prosomnus sleep technologies | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | April 6, 2026 |
| K233497 | somnomed | Rest Assure System | October 3, 2024 |
| K190353 | residential home sleep services | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | April 10, 2020 |
| K181571 | mark abramson, d.d.s | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | April 19, 2019 |
| K172859 | prosomnous sleep technologies | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device | November 22, 2017 |
| K170606 | gergen orthodontic lab | Acrylic Herbst Appliance with Micro-Recorder | November 16, 2017 |
| K161624 | microdental | MicrO2 OSA Device with Micro-Recorder | November 7, 2016 |
| K160239 | airway management | TAP 3, TAP 1 | August 10, 2016 |
| K150369 | somnomed | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac M | June 18, 2015 |