Court Finds Propel’s VPro5™ is an FDA Class I Device That Can Continue to be Sold as an Aligner Seater

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FDA announcement on VPro5™ as Class I device

Yesterday, a U.S. District Court in the Eastern District of Texas Court (case 4:16-cv-00350) ruled that Propel Orthodontics was fully able to continue to market its VPro5™ vibratory orthodontic device as an aligner seater.

The Court also endorsed what Propel has contended all along – that the VPro5™ is and always has been an FDA-compliant Class I medical device. Further, the Court specifically ordered that Propel can continue to market its VPro5™ device, and can continue telling doctors everywhere about the VPro5™’s benefits as an aligner seater.

This is good news for Propel, said Bryce Way, CEO of Propel, because “our doctors are purchasing and reordering the VPro5™ as a device to aid in aligner seating and are choosing the VPro5™ because it effectively seats aligners with only 5 minutes of use.” Mr. Way further noted that “we never made claims such as ‘tooth remodeling’ and we never compared our product to any competing product and so the Court’s ruling doesn’t require significant changes to our marketing.”

Following the recent revelation that, since at least late 2015, OrthoAccel has been in possession of medical and scientific evidence that its AcceleDent Aura® devices are not effective to accelerate tooth movement when used with clear aligners, AcceleDent has been touting the alleged benefits of its product for aligner seating.

Propel is proud to offer the VPro5™ as part of its line of award-winning products. “We at Propel are pleased that we can continue to offer doctors the best, most cost-effective solution for use with clear aligners” said Mr. Way.

The VPro5™ is the first and only product specifically developed as an aligner seater. Propel is continuing to build its clinical trial data and is confident the results of these trials will demonstrate the clinical benefits of the VPro5™. Propel is happy to be able to continue to offer the VPro5™ as an aligner seater.

Propel is confident that the VPro5™ is the best aligner seater on the market. To that end, Bryce Way asks that the dentists and orthodontists “be the judge” and try the VPro5™ in their practice free of charge. Mr. Way noted that “we are confident that if they try the VPro5™ with their patients, the doctors will always choose the VPro5™ for aligner seating.”

To order your complimentary sample VPro5™ doctors should call 855-377-6735 or e-mail info(at)propelortho(dot)com

Mr. Way concluded that “Propel is appreciative of all the doctors who have showed ongoing support and enthusiasm for Propel and its line of award-winning products, including the VPro5™ and looks forward to providing cutting edge products to the industry for many years to come.”

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Calvin J. Fortenberry

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