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510(k) Data Aggregation
K Number
K182661Device Name
Kava and Kava with Herbst
Manufacturer
Date Cleared
2019-02-13
(141 days)
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
Sketchpad Innovations LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Kava and Kava with Herbst device(s) are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Device Description
The Kava and Kava with Herbst are simple hardware devices. They are oral appliances and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients.
The Kava and Kava with Herbst are intra-oral devices used for treating snoring and mild to moderate Obstructive Sleep Apnea (OSA). They consists of two custom fitted trays which fit over the upper and lower dentition of a patient and engage by means of adjustable metal screws or lugs. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air.
The devices are retained on the teeth by labial and lingual positioned ball clasps, typically located in the undercuts of each splint.
The devices are custom made for each patient and have an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.
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