PLC · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5570
Classification
FDA Product Code
PLC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 872.5570
Review panel
DE
Medical specialty
Dental
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
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.