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510(k) Data Aggregation
K Number
K060122Device Name
SLEEP SPLINT
Manufacturer
Date Cleared
2006-05-19
(122 days)
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
NAKAGAWA DENTAL CLINIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sleep Splint is intended to be prescribed to adult patients to aid in the reduction and management of snoring and mild to moderate obstructive sleep apnea.
Device Description
The Sleep Splint is a prescription only, intraoral appliance that is fitted to the upper and lower teeth, and worn during sleep for the purpose of reducing the incidence of snoring and obstructive sleep apnea. The Sleep Splint is made of copolyester (acrylic resin for the previous version) and features an orthodontic resin bond which can be custom-fitted by a dentist. It comfortably holds the mandible 5 mm to 7 mm forward.
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