The approval of HAnano Surface in the United States has been executed in accordance with the new 510(k) legislation for medical devices.
STOCKHOLM, December 14, 2017. Karolinska Development announces today that the portfolio company Promimic has received approval from the U.S. Food and Drug Administration (FDA) for the use of HAnano Surface as a dental implant coating. Promimic’s partner S.I.N. is currently preparing a U.S. launch of Unitite (TM) - a line of dental implants coated with HAnano Surface.
The approval of HAnano Surface in the United States has been executed in accordance with the new 510(k) legislation for medical devices. After this approval several other submissions will be filed to the FDA during 2018, particularly in the orthopedic area.
“The FDA approval allows for a rapid launch in the United States of dental implants coated with HAnano Surface - a unique technology that improves the integration of the implant into bone tissue and allows the patient to rapidly regain normal dental function after the surgical procedure,” says Viktor Drvota, CEO, Karolinska Development.
In 2016, Promimic’s partner S.I.N. launched the dental implant line Unitite(TM) in Brazil.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com
Fredrik Järrsten, CFO, Karolinska Development AB
Phone: +46 70 496 46 28, e-mail: fredrik.jarrsten@karolinskadevelopment.com
