Sleep Appliances With Patient Monitoring
The Sleep Appliances With Patient Monitoring (product code PLC) is a Class 2 dental device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years and older, while also measuring patient compliance with oral appliance therapy, regulated under 872.5570. It requires 510(k) clearance and is eligible for third-party review. The device is not flagged as an implant or life-sustaining product.
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Basic Information
- Product Code
- PLC
- Device Class
- FDA class 2
- Regulation Number
- 872.5570
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | Apr 06, 2026 | Substantially Equivalent | Prosomnus Sleep Technologies |
| K233497 | Rest Assure System | Oct 03, 2024 | Substantially Equivalent | Somnomed, Inc. |
| K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | Apr 10, 2020 | Substantially Equivalent | Residential Home Sleep Services |
| K181571 | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | Apr 19, 2019 | Substantially Equivalent | Mark Abramson, D.D.S., Inc. |
| K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder | Nov 22, 2017 | Substantially Equivalent | Prosomnous Sleep Technologies |
| K170606 | Acrylic Herbst Appliance with Micro-Recorder | Nov 16, 2017 | Substantially Equivalent | Gergen'S Orthodontic Lab |
| K161624 | MicrO2 OSA Device with Micro-Recorder | Nov 07, 2016 | Substantially Equivalent | Microdental, Inc. |
| K160239 | TAP 3, TAP 1 | Aug 10, 2016 | Substantially Equivalent | Airway Management, Inc. |
| 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 | Jun 18, 2015 | Substantially Equivalent | Somnomed, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.