It is key to our strategy concerning sustainable development that, in spite of our strong growth, we continuously improve the quality of our operations, products and services. Our quality policy therefore emphasizes that we make no compromise on safety or quality, and that we continuously innovate and improve our processes.
CeraRoot and its products are certified by BSI, Notified Body Number 2797.
The company holds BSI certificate n° MD 663093, MDSAP 710650 and operates a Quality Management System which complies with the requirements of ISO 13485: 2016.
The CeraRoot zirconium oxide implants carry the CE Mark in Class II.
The implementation of our quality policy is secured by an integrated quality management system compliant with the laws and regulations concerning Medical Technology, including EU MDD 93/42/EEC and ISO 13485. Click at the image below to zoom in.
|ISO 13485 , CMDCAS||EN ISO 13485||CE CERTIFICATE|
The U.S. Food and Drug Administration has given CeraRoot S.L. authorization to sell products to the U.S. territory. Since January 2011, more and more dentists are extremely satisfied with the quality of CeraRoot products. Click at the image below to zoom in.
Health Canada has given CeraRoot S.L. authorization to sell products in the Canada territory. Since November 2011, more and more dentists are extremely satisfied with the quality of CeraRoot products. Click at the image below to zoom in.
Company ID: 132633
Licence No.: 87566
Device class: 3
Device first issue date: 2011-11-04
Licence name: CERAROOT ZIRCONIUM OXIDE DENTAL IMPLANT
Level 20, Tower II
201 Sussex Street
Sydney, NSW 2000 Australia