Product Classification

• 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 Code: PLC
• 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 Reporting: Eligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 4-295 ADA ANSI Standard No. 41-2020
  Evaluation of Biocompatibility of Medical Devices Used in Dentistry

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock consulting
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc