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Tongue Suspension System

FDA product code ORY · 9 cleared devices

Class 2 Dental
Regulation
21 CFR 872.5570
Review panel
DE
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2010-07-08 – 2021-12-22

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.

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