Quality Assurance

 GDT Implants Complies With High Quality Control Standards:
  • Products carry the CE mark that includes visits from the European Medical Device Directive (93/42/EEC).
  • Major quality control system is in compliance with EN ISO 13485:2016 and FDA QSR 21 CFR Part 820
  • The facilities are subject to routine inspection by international inspectors.

 

Surface Treatment

The implant rough surface topography combines macro roughness, produced using sandblasting and micro roughness created by acid-etching process. The resulting topography ensures reliable osseointegration.

GDT implants are made of Titanium alloy Ti 6Al 4V ELI, Titanium implants with adequate roughness influence the primary stability of implants, enhance bone-to-implant contact, and increase removal torque force.

The surface roughness of the implants can significantly alter the process of osseointegration because the cells react differently to smooth and rough surfaces: osteoblastic proliferation and collagen synthesis are increased on rough surfaces.

GDT Implants focused its research on the factor of surface roughness and we used various techniques in order to compare our results with the best, universally recognized implant manufacturers.

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