December 2017
HAnano Surface® cleared for use on dental implants by FDA
GOTEHNBURG – December 14, 2017. Promimic announces that the Food and Drug Administration (FDA) has approved our HAnano Surface for use on dental implants in the USA with our partners S.I.N. The implant line Unitite was first launched in Brazil in 2016 and after this approval S.I.N plans to introduce Unitite on the US market.
This is Promimic’s second FDA clearance for the HAnano Surface and our first according to the new FDA legislation for 510(k) medical devices. The clearance will be followed by several FDA submissions during 2018, particularly in the orthopedic area.
Read the press release