LSWD...
The LSWD is a mandibular advancement device. It is inserted in the mouth and fits on the palate like a retainer. It has a “protrusive element” (PE) which rests behind the lower anterior teeth to maintain them in a comfortable forward position. This allows the lower jaw to move freely from side to side as well as open slightly. The appliance will be dispensed with a “suck down” for lower anteriors which can be used as necessary. The protrusive element will extend downward approximately 10mm and thus prevent the lower teeth from disengaging it. Most unique is the feature that there is an anterior stop (no material on the posterior teeth) which serves to minimize clenching. Since clenching is a necessary component of bruxing, it will reduce bruxing as well. The patent is pending and it is FDA accepted for snoring.
FDA 510 (k) for snoring. K062333
Trade Name Lamberg Sleep Well Device
Regulation Numberg: 872.5570
Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK
Dated: December 7, 2006
Received: December 7, 2006
