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U.S. Department of Health and Human Services

Product Classification

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Device sleep appliances with patient monitoring
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
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.
Physical State Comprised of two customized splints (upper and lower) held together by a locking mechanism
Technical Method advances the patient's mandible in a forward position to increase airway space and additionally monitors the patient compliance to oral appliance therapy
Target Area Patient's oral cavity
Regulation Medical Specialty Dental
Review Panel Dental
Product CodePLC
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT 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
Implanted Device? No
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review
Accredited Persons