Quality & Certificates

EUROPE

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 663090 and operates a Quality Management System which complies with the requirements of ISO 13485: 2016.

The company holds BSI certificate n° FM 663085 and operates a Quality Management System which complies with the requirements of ISO 13485: 2003.

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/ECC and ISO 13485. Click at the image below to zoom in.

 ISO 13485 , CMDCAS  EN ISO 13485  CE CERTIFICATE

USA

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.

FDA Link: http://www.accessdata.fda.gov/SCRIPTS/cdrh/cfdocs/cfRL/rl.cfm?rid=124887

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CANADA

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.

CERAROOT SL.

 

 

 

 

 

 

   

CeraRoot S.L  
c/ Parpers 13, 08520  Les Franqueses del Vallès,
Barcelona. Spain.


Company ID:
132633

Licence No.: 87566

Type: Device Family
Device class: 3
Device first issue date: 2011-11-04
Licence name: CERAROOT ZIRCONIUM OXIDE DENTAL IMPLANT

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AUSTRALIA

Australian Sponsor:

Emergo Australia
Level 20, Tower II
Darling Park
201 Sussex Street
Sydney, NSW 2000 Australia

 
Manufacturer:

 

 

 

 

 

 

 

 

 

 

 

 

CeraRoot S.L  
c/ Parpers 13, 08520  Les Franqueses del Vallès,
Barcelona. Spain.
 
ARTG Entry:  CeraRoot Surgical Kit (drills)  Class IIa  (see official PDF)
ARTG Entry:  CeraRoot Surgical Kit (rest of instruments)  Class I  (see official PDF)