somnoguard 2.0...

One-part thermoplastic mandibular advancement device to treat snoring and mild to moderate obstructive sleep apnoea. Appliance consists of a hypoallergenic thermoplastic body. After heating the appliance in water that has been boiled the thermoplastic co-polymer becomes soft and mouldable. While soft, the appliance is fitted to the upper and lower jaws and once cooled it is ready to be worn at night. It differs from the preceding SomnoGuard by a 3.0 mm thicker molar biting zone. This thicker molar area means that fitting is faster and easier for those patients with a "deep bite". The monobloc appliance exhibits the following features and advantages:

• Easy fitting within minutes, preferably by physicians or their trained staff
• Clinical efficacy well proven by several clinical trials performed with the SomnoGuard® with success rates between 50 to 80% in reducing snoring and RDI (i.e. Respiratory Disturbance Index). Literature references and detailed actual clinical trial outcome data is published on www.tomedcare.com
• Normally very well tolerated. Minor and temporary side effects refer mainly to hypersalivation and morning discomfort
• Average life of about one year, and thus considered for short to medium term use
• The most cost-effective option to treat snoring and sleep apnoea

Dental lab made two-part mandibular adjustable positioner to treat snoring and mild to moderate sleep apnoea. The SomnoGuard® AP Pro can easily be constructed from common acrylic/elastomeric thermoform dental materials in any detal lab after taking impressions of the lower and upper jaws and producing plaster models. The components used to connect the upper and lower trays of the dental appliance and enable the infinite advancement of the lower jaw are made from stainless steel. The components' technology is based on the preceding development of the SomnoGuard® AP. The components are very durable, more or less inndestructable, inexpensive and can most often be reused when the oral appliance has to re-made for some reason. As well as the advantages of the SomnoGuard ®AP, the dental device SomnoGuard® AP Pro provides the additional benefit that even patients with missing teeth or dentures can wear it. SomnoGuard® AP Pro is considered for long term use between about three to five years or longer.

FDA Approval received for the complete line of SomnoGuard oral appliances (the 1-part boil & bite devices SomnoGuard and SomnoGuard 2.0, the 2-part adjustable boil & bite SomnoGuard AP and the two part custom made SomnoGuard AP Pro for fabrication by dental labs) the FDA 510(k) approval under the clearance number "K061688" on September 8, 2006