Thursday, November 10, 2016
Propel Orthodontics reasserts the status of its VPro5™ as an FDA-compliant Class I medical device in response to misinformation circulated within the orthodontic community by a competitor. Propel Orthodontics announces that it recently received confirmation from the Food and Drug Administration that the FDA has successfully concluded its inspection of the Propel Orthodontics manufacturing facility for the VPro5™, an FDA Class I device that the FDA notes "is a device that vibrates to assist clear plastic aligners fit to a patient's teeth."
"We're really pleased – but not surprised – that Propel passed the FDA inspection with flying colors," said Bryce Way, President of Propel Orthodontics. Mr. Way went on to note that the FDA reviewed Propel Orthodontics' marketing materials for the VPro5™ and found no issues with any of them.
In late October, a judge noted that the VPro5™ is "a vibratory Class I device designed to help seat clear aligners," and specifically ordered that Propel can continue to market the VPro5™ device to dentists and orthodontists.
Yet doctors are continuing to be misled by a competitor's false claims that the VPro5™ is not FDA compliant. The VPro5™ is the first and only product specifically developed as an aligner seater for clear aligners. Properly seated aligners are crucial in helping doctors meet their goals and their patients' goals. Propel is continuing to build its clinical trial data and is confident the results of these trials will demonstrate additional benefits of using the VPro5™. Propel has also launched its "You Be the Judge" campaign where doctors can try the VPro5™ for free, with no obligation.
"It's a travesty that there is a concerted effort to remove our product from the marketplace by spreading misinformation about the VPro5™," said Peter Migneault, Executive Vice President of Propel Orthodontics. "Propel wants all doctors to know and be assured that the VPro5™ is fully FDA compliant."
Source : finance.yahoo.com
