PLC

Sleep Appliances With Patient Monitoring

Product code

PLC

Device name

Sleep Appliances With Patient Monitoring

Device class

Class 2

21 CFR

21 CFR 872.5570

Medical specialty

Dental

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (last 3 years)

3

Summaries archived here

1 (direct download)

510(k) clearances (all years, FDA)

10 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-08-25.

1 summaries are archived here for direct download.