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510(k) Data Aggregation
K Number
K051014Device Name
SILENT PARTNER SERIES OSA APPLIANCES
Manufacturer
Date Cleared
2005-08-09
(110 days)
Product Code
Regulation Number
872.5570Why did this record match?
Applicant Name (Manufacturer) :
DREAMWRX DENTAL LABORATORY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Reduce nighttime snoring and/or mild to moderate obstructive sleep apnea by repositioning of the mandible.
Device Description
The device consists of a lower tray fitted over the lower teeth, an upper tray over the upper teeth, and a mechanism to attach the lower to the upper tray. The device allows the practitioner to determine the advancement of the mandible and the vertical opening for desired results. This technology platform consists of a stylus, slider, and the channels into which they are placed; these parts are identical in both models.
The device has a 10 mm long channel in the lower tray behind the anterior teeth that is perpendicular to the patient's tongue. This allows the upper component, which locks into the channel, to provide lateral excursion for the patient's comfort. Prior to final insertion the upper and lower trays are connected together by keying the stylus into the lower channel. The device's upper component consists of a 16 mm long titanium channel into which a nine-position latched slider will let the practitioner place the stylus in the optimum position. Both the slider and the stylus are placed into the channel's frontal opening and securely locked into place by tension attachment.
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