Product code PLC

Device name

Sleep Appliances With Patient Monitoring

Medical specialty

Dental

Device class

2

Regulation number

872.5570

Review panel

DE

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset