ORY · Class II — Moderate Risk (510(k) clearance required) · Dental · 21 CFR 872.5570
Classification
FDA Product Code
ORY
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
Y
Third-party review
N
Definition
Intended to be used for anterior advancement of the tongue base by means of a bone screw threaded with a suture. It is indicated for the treatment of obstructive sleep apnea (OSA) and/or snoring.