Propel Orthodontics, Ossining, NY, has received a 510(k) marketing clearance from the US Food and Drug Administration (FDA) for its Excellerator orthodontic driver. The Propel Excellerator has been cleared as a Class II medical device for preparing bone and tissue for orthodontic procedures.
“Propel’s patented Excellerator drivers are specifically designed to create perforations, and have become the preferred device of leading clinicians,” said Bruce Way, CEO and President of Propel. “Propel Excellerator drivers facilitate ideal results in both simple cases as well as complex malocclusions in conjunction with braces and clear aligners.”
Propel Chairman Richard Johnson, MD, added, “The FDA clearance of our Excellerator drivers as a Class II device is an important milestone for Propel. As a company, we share our doctors’ commitment to providing patients with safe and effective care. The Propel Excellerator is a unique device that offers important benefits for patients and clinicians alike.”
Propel is a certified ISO 13485 manufacturer and has a CE Mark approval for sale in the European Union. Propel Excellerators have also received regulatory clearance in Canada, Taiwan, New Zealand, Singapore, Vietnam, Hong Kong, Malaysia, and Australia.