Product Classification

• Device: expiratory resistance valve, intranasal, for obstructive sleep apnea
• Regulation Description: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
• Definition: Intranasal device that creates expiratory resistance for the treatment of obstructive sleep apnea.
• Physical State: plastic with adhesive; valve that changes position with inspiration/expiration to provide decreased/increased resistance
• Technical Method: intranasal device that creates expiratory resistance
• Target Area: inserted into nares of nose to maintain upper airway pressure.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: OHP
• 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