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A customized mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.

The Medley Gold series oral appliance design concept is based upon the use of a standard set of upper and lower trays that have been customized by a dentist that then may have one of three (3) options attached to the trays to act as a Mandibular Repositioning Device (MRD). The rationale for have a single set of customized trays that may have different MRD methods attached is that some patients have a personal preference and some configurations are more comfortable for them. Therefore rather than having to make another set of custom travs, the dentist may use the same trays and just change the method of MRD, i.e. bands, links, or rods, to the same set of trays. The principle of advancing a lower tray so that it advances the mandible for the treatment of snoring and / or obstructive sleep apnea is well known and there a number of predicate devices. The proposed Medley Gold device has three (3) methods of advancing the lower tray based upon the identical designs of 3 already cleared predicate designs. 1) Bands a. K971794 - Frantz EMA 2) Links a. K113201 ResMed Narval CC 3) Rods a. K023836 Strong SUAD