News
News from and about Tomed.Interesting to know
1) Marketing approvals
It was a major achievement for the prefabricated SomnoGuard AP, the custom-made SomnoGuard AP Pro and the prefabricated one-part devides SomnoGuard and SomnoGuard 2.0 oral appliances to have the American FDA 510(k) approval added to our existing European CE marking and others in the year 2006. We plan to file for the FDA marketing approval regarding the remaining SomnoGuard SP series in 2012. Then, we had been awarded the important and prestigious ISO 13485 certification for Tomed's quality management system in 2009 (click). We now have marketing approval for our series of cost-effective and efficacious oral appliances in all major developed countries of the world.
It was a major achievement for the prefabricated SomnoGuard AP, the custom-made SomnoGuard AP Pro and the prefabricated one-part devides SomnoGuard and SomnoGuard 2.0 oral appliances to have the American FDA 510(k) approval added to our existing European CE marking and others in the year 2006. We plan to file for the FDA marketing approval regarding the remaining SomnoGuard SP series in 2012. Then, we had been awarded the important and prestigious ISO 13485 certification for Tomed's quality management system in 2009 (click). We now have marketing approval for our series of cost-effective and efficacious oral appliances in all major developed countries of the world.
2) Considered new product launch
Based on the telescopic variants of the prefabricated devices SomnoGuard SP Soft and Hard another custom made oral appliance, i.e. SomnoGuard SP Pro, is now at the final stages of its development. This new custom made mandibular advancement device from Tomed will be supplied with both plastic made telescopic and standard connectors of variable length to set the preferred lower jaw advancement. The same connectors can be used with the corresponding prefabricated oral appliances SomnoGuard SP Soft and Hard too. Use of the telescopes connectors will enable patients to open their mouth widely with ease whenever required and without any changes to the preset lower jaw advancement.
Based on the telescopic variants of the prefabricated devices SomnoGuard SP Soft and Hard another custom made oral appliance, i.e. SomnoGuard SP Pro, is now at the final stages of its development. This new custom made mandibular advancement device from Tomed will be supplied with both plastic made telescopic and standard connectors of variable length to set the preferred lower jaw advancement. The same connectors can be used with the corresponding prefabricated oral appliances SomnoGuard SP Soft and Hard too. Use of the telescopes connectors will enable patients to open their mouth widely with ease whenever required and without any changes to the preset lower jaw advancement.
Telescopic connectors being prolonged and not prolonged
3) Commercial insight: questionable practices of sleep dentists against Tomed
Our prefabricated oral appliances SomnoGuard, SomnoGuard 2.0 and SomnoGuard AP are many times cheaper than the custom-made appliances, but not necessarily less effective. Due to the tremendous price differences between our prefabricated and the major brands of custom-made oral appliances for the treatment of primary snoring and mild to moderate obstructive sleep apnoea in adult patients some few sleep dentists have been combatting us for years. Thus, we have decided to disclose some of the available facts to our customers and other interested parties to enable them to draw their own conclusions and make up their mind about the seriousness of those experts.
click to read more about the documented facts
Our prefabricated oral appliances SomnoGuard, SomnoGuard 2.0 and SomnoGuard AP are many times cheaper than the custom-made appliances, but not necessarily less effective. Due to the tremendous price differences between our prefabricated and the major brands of custom-made oral appliances for the treatment of primary snoring and mild to moderate obstructive sleep apnoea in adult patients some few sleep dentists have been combatting us for years. Thus, we have decided to disclose some of the available facts to our customers and other interested parties to enable them to draw their own conclusions and make up their mind about the seriousness of those experts.
click to read more about the documented facts