Pure Global AI
FDA product code ORY

Tongue Suspension System

DentalClass 221 CFR 872.5570Implantable
Verified
US regulatory classifications
US Product Code (FDA)
ORY
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 872.5570
View CFR Regulation
Medical specialty
Dental
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
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.

Search keywords

Click to search for similar devices in our global database

01tongue suspension02sleep apnea03airway device04snoring device05OSA treatment06oral appliance07sleep surgery08airway support09medical implant10pharyngeal support
About this record

Tongue Suspension System is a medical device type in the Dental specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.