SomnoDent Fusion is an FDA 510(k)-cleared, class II medical device manufactured under 21 CFR 820 and ISO13485 standards. Significant clinical benefits have been demonstrated in 15 independent studies, one with 91% of patients reporting improvement in sleep quality with SomnoDent.
SomnoDent Fusion™ Benefits
- Quick advancement with interchangeable wings providing a 8.5mm range and fine screw adjustments at .1mm increments
- Proprietary SMH BFlex lining that does not attract odors or delaminate; also available with ball clasp retention
- Supported by years of medical research
- 3 year product warranty against manufacturing defects
- FDA 510(k) cleared, Class II Medical Devices
- All devices manufactured under 21 CFR 820 and ISO 13485 standards
SomnoDent Fusion Demonstration Video
The calibration flexibility offered in the SomnoDent Fusion means that it does not have to be reset as frequently, and less resets means your patients won’t be without their device during manufacturer adjustments. With device wings that are closer to the occlusal surface, patients experience more room in their mouths and less bulk! Along with the flexibility in adjustment, the SomnoDent Fusion provides an 8.5mm advancement – longer than most other dorsal fin oral devices. The SomnoDent Fusion can also be made with SMH BFlex material, which creates greater comfort for your patients. Ultimately, the SomnoDent Fusion saves your office time and money with our drop-in fit, along with less device adjustments afterwards.
12 evaluators described the SomnoDent Fusion as much or somewhat better than similar products, with most (8) describing it as much better.
Click here to view the full evaluation and report.
”I LOVE the new Fusion oral appliance by SomnoMed. With the wing movement of 1 mm each, and the capability of changing out 4 different wings,plus the original maxillary screw mechanism that allows 6mm of movement … this gives the dentist a lot of options/combinations of movement to get the patient to an optimal and therapeutic spot to manage their sleep apnea. This will be my go to appliance for a long time.”
– Dr. Erika Mason, DDS, Diplomate-ABDSM, Diplomate-ACSDD
Let us partner with you for improved patient choice
SomnoMed is more than a device company, we’re your partner for the better patient care and compliance. Contact us today to speak with a SomnoDent advisor or for more information.