St. Ann, Missouri, USA, August 15, 2012
For Immediate Release — “Today’s announcement marks one of the most significant milestones in DynaFlex history,” said Darren Buddemeyer President and CEO of DynaFlex.
“Not only does EZ-Align® (K121396) have the potential to be a significant growth driver for DynaFlex, it also represents a fundamental step forward in the sequential aligner technology using our proactive management style.”
“Developing medical devices can be a major challenge for any organization, but for us to have achieved 510(k) clearance from the FDA is an outstanding accomplishment which we are very proud of as a company. These achievements further illustrate the DynaFlex commitment to regulatory requirements, and assurance that our devices are made with utmost safety requirements.
FDA 510(k): Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. It is a rigorous and arduous documentation and compliance process.
DynaFlex is a leading provider of Orthodontic Products, Orthodontic Custom Lab Manufacturing, Sleep Apnea Appliances, and Digital Orthodontic Products and Services.
Established in 1965, DynaFlex is now one of the fastest growing Orthodontic Supply & Lab providers in the industry. We are proud to provide “above and beyond” outstanding customer service, combined with the best products, high- quality manufacturing, state of the art technology, and a stellar, market- leading unique proactive leadership approach.
DynaFlex is an ISO 13485:2003 & MDD 93/42/EEC Certified Company.
ISO and Quality Manager