CeraRoot® history

Innovation guided by biology and standards

2005 - Patent is filed for the CeraRoot implant system (P200502865)
2006 - CeraRoot receives first ISO 13485 and CE certificate by Notified Body CE1275
2010 - Patent is published for the CeraRoot implant system (P200502865)
2011 - FDA clearance letter to market the CeraRoot implant system in USA.
2011 - CeraRoot receives first CMDCAS certificate and Health Canada licences to market the products in Canada.
2012 - CeraRoot opens new subsidiary in Santa Monica , California, for the distribution of products in America.
2014 - CeraRoot changes Notified Body to BSI group to provide the best Quality Products to our customers.
2018 - Australian Therapeutic Goods Administration (TGA) gives ARTG 300125 to market the ceramic implant in Australia.
2019 - CeraRoot opens new Headquarters in Les Franqueses, Barcelona.
2019 - First issue of MDSAP certificate by BSI for the markets: USA, CANADA, AUSTRALIA, and JAPAN.
2020 - Registration to EUDAMED according to new European Medical Device Regulation (EU)2017/745. SRN: ES-MF-000000251
2020 - Patent for the CereaRoot Tissue Level (TL) ceramic implant is filed at both the US (www.uspto.gov) and European (www.epo.org) patent offices.
2021 - CeraRoot receives EU Medical Device Regulation Quality Management Certificate, as the first ceramic dental implant company to be accredited.
2025- CeraRoot receives FDA approval (510k) for the CeraRoot TL (two-piece) implant.

Surgery