EUROLAB laboratory provides testing and compliance services within the scope of EN ISO 13504 standard. EN ISO 13504 specifies general requirements for the manufacture of instruments and related accessories for the placement of dental implants and for further manipulations of fittings in the craniofacial area.
It can be applied to disposable and reusable devices, regardless of whether they are manually operated or connected to a powered system.
The use of dental implants is increasing all over the world. Due to the improved and new applications of dental implants, the need for better instruments and related accessories to be used in the placement of dental implants and greater manipulation of fittings in the craniofacial region is also increasing. Dental implants must be approved by local authorities.
However, the instruments used to place dental implants are different and require a different approval procedure. This International standard aims to harmonize approval procedures and reduce the costs associated with repeated approval and testing procedures in different countries.
Materials found in instruments used in dental implant procedures have proven to be well tolerated. Potential adverse reactions cannot be completely ruled out, but such reactions should be mitigated.
However, long-term clinical experience with the use of materials referred to in this International standard has shown that an acceptable level of biological response can be expected when used in appropriate applications and when instruments are manufactured under appropriate design considerations and processes.
EUROLAB assists manufacturers with EN ISO 13504 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
