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U.S. Department of Health and Human Services

Product Classification

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Device prelude tongue suspension system
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
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.
Physical State Bone screw and suture material
Technical Method Physical advancement of the tongue.
Target Area Oral cavity
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeORY
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Dental Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.5570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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