Unmask Sleep Apnea: Experience the SomnoDent™ Difference
As the global leader in Continuous Open Airway Therapy (COAT)®, SomnoMed® provides clinically proven treatment options for obstructive sleep apnea (OSA) and sleep bruxism.
Characteristics of a High-Quality Oral Device
For many years, oral devices have been a cottage industry with individual dental labs across the country making their own “custom” devices. Because Obstructive Sleep Apnea is a medical condition, prescribing a high-quality medical device will ensure patients are treated with a product proven to successfully treat this chronic condition.
Evidence-Based:Clinical evidence demonstrating the efficacy of treatment through more than 17 clinical studies.
Comfortable: Designed with proprietary materials, SomnoDent devices are known for their custom fit.
FDA cleared: reviewed, 510(k) cleared medical devices; Manufactured under ISO13485 medical device Quality Management System.
Durable: Warrantied against manufacturing defects for 1 year or longer with a device life expectancy of 3-5 years.
Technologically advanced materials that improve patient comfort and product function.
Compliant: Compliance recording function to measure a patient’s adherence to treatment.
Customized: Patient-specific and fitted by a qualified sleep dentist.
SomnoDent patients experience Better Sleep. 9 out of 10 SomnoDent patients report improvement in sleep quality1. Our patients simply sleep better! Improved Compliance is shown in 88% of SomnoDent patients who reported regular use of their SomnoDent device1 enhancing efficacy of treatment. SomnoDent’s unique SMH BFlex technology provides Unparalleled Comfort2 which increases compliance with the device.
Fit Matters: Why You Should Choose SomnoDent
For patients with mild to moderate obstructive sleep apnea (OSA) — the comfort and quality of their device are paramount to them receiving full clinical benefit. Since 2004, SomnoMed has manufactured devices meeting the highest level quality and service standards. As a professional partner, SomnoMed has helped physicians recognize the important characteristics of a high-quality oral device when prescribing COAT (Continuous Open Airway Therapy).
As a professional partner, SomnoMed has helped physicians recognize the important characteristics of a high-quality oral device when prescribing COAT.
SomnoDent is also the first dorsal device to offer compliance recording technology in the US. Using SomnoDent with compliance recording, SomnoMed’s proprietary compliance recording technology, your patients will experience the same compliance benefits as CPAP in an oral device.
How SomnoDent Compares
Over 400,000 patients treated.
ISO13485 and FDA 510(k) cleared medical devices.
Product lines that feature premium and lower cost dorsal devices as well as E0486 approved devices.
Made with high-quality materials such as proprietary SMH BFlex.
Offers premium comfort for patients. Almost 9 out of 10 patients rated the comfort of their SomnoDent device as good or better.1
Strong clinical evidence base with over 17 clinical studies. 91% of patients reported improvement in sleep quality with SomnoDent.2
Growing dental network with over 2,500 dentists nationwide.
First and only dorsal device with proprietary compliance recording technology similar to CPAP.
Edentulous devices available.
SomnoDent devices are fully repairable.
Device warranties up to 3 years.
Have questions about treating your obstructive sleep apnea (OSA) patients with SomnoDent oral devices? Contact us or call 1-888-447-6673
AM / Respir Crit Care Med Vol 163. Pp 1457-1461, 2001
SMH BFlex not available in Classic Device.
Home > Médecins > Caractéristiques de les dispositifs médicaux de qualité
Caractéristiques de les dispositifs médicaux de qualité
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Édentement
La gamme SomnoDent: Des dispositifs médicaux de premier rang validés cliniquement
Leader mondial dans la thérapie consistant à garder les voies respiratoires ouvertes (COAT), nous fournissons des options de traitement validées par de nombreuses études cliniques (plus de 25 études indépendantes sont à votre dispositions) pour l’apnée obstructive du sommeil (AOS), le ronflement et le bruxisme de nuit.
Pendant plusieurs années, les OAM provenaient de l’industrie artisanale avec des laboratoires dentaires isolés à travers le pays, fabriquant eux-mêmes les appareils «sur-mesure». Parce que l’apnée obstructive du sommeil est une affection médicale, prescrire un dispositif médical de haute qualité, assurera aux patients un soin avec un produit destiné à traiter avec succès cette maladie chronique.
Orthèses d’avancée mandibulaire «spécifique au patient» qui est installée par un dentiste spécialiste du sommeil après prise d’empreinte
La FDA a examiné, 510 000 dispositifs médicaux
Fabriqué sous le dispositif médical ISO13485 du système de gestion de qualité
Preuve clinique solide démontrant l’efficacité du traitement
Produit durable avec garantie contre les défauts de fabrication (1 an)
Matériaux de technologie avancée qui améliorent le confort du patient et l’efficacité a moyen et long terme du traitement
Fonction d’enregistrement de l’observance pour mesurer l’adhésion du patient au traitement
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