DeviceClearance

Product code PLC— Dental

Acrylic Herbst Appliance with Micro-Recorder

Classification name
Sleep Appliances With Patient Monitoring
Device class
Class 2
Regulation
21 CFR 872.5570
Advisory panel
Dental
Total cleared
10
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PLC under 21 CFR 872.5570, via openFDA

Market context for product code PLC

FDA has cleared 10 devices under product code PLC between 2015 and 2026, filed by 9 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PLC

Recent clearances under product code PLC

Data sourced from openFDA. This site is unofficial and independent of the FDA.