Quality Assurance
GDT Dental Implants
Upholds Rigorous Standards for Quality Control
Our products carry the CE mark, meeting the European Medical Device Directive
Our products are FDA cleared under the Clearance Premarket Notification (510k) and the quality control standard: ISO 13485:2016
Our production facilities are routinely subjected to audits and visits by international supervisors
GDT Dental Implants is fully dedicated to the highest medical standards and quality assurance regulations recognized worldwide. With the intent of showcasing our commitment to patients' safety and their well-being, we have adamantly pursued and achieved numerous regulatory certifications.
GDT Dental Implants emphasizes that each one of our products is developed with special care and is finely tuned down to the smallest detail, as we embrace cutting-edge, high-tech equipment during our production process, pushing the limits of innovation in our field of expertise.
Our aim is to deliver products that seamlessly integrate with the needs of our valued clients and their patients, as we strive to leverage the latest technological advancements to provide solutions that are not only well-fitted, but also highly useful and effective.
All GDT Dental Implants are packaged in a Clean Room ISO 7 (Class 10,000),
maintaining the highest standards of sterilization and quality.
MATERIAL
GDT Implants made from Titanium alloy grade 5
Ti 6Al 4V ELI, renowned for its exceptional properties.
This Titanium alloy known for its low specific weight, high strength-to-weight ratio, outstanding corrosion resistance, and remarkable biocompatibility with the human body.
What sets Ti 6Al 4V ELI apart is its “Extra Low Interstitials” (ELI) designation, which means reduced levels of oxygen, nitrogen, carbon, and iron.
As a result, it offers improved ductility and better fracture toughness.
These qualities have made Titanium alloy grade 5 Ti 6Al 4V ELI highly successful in manufacturing realiable dental implants.
Implant Surface Treatments
SLA
Sandblasted, large grit, acid-etched
2000x magnification
SLA is a type of surface treatment that creates surface roughness intending to enhance osseointegration through greater
bone-to-implant contact (BIC).
The advanced technology behind SLA involves a two-step process.
Firstly, a large-grit sandblasting technique is employed to create a macro-roughness on the titanium surface.
Subsequently, an acid-etching step is implemented, superposing a micro-roughness that provides an excellent structure for cell attachment.
By combining grit and acid etching, SLA significantly increases the surface roughness on multiple levels.
This enhanced roughness enables osteoblasts to proliferate and firmly adhere to the implant surface.
Therefore, osseointegration is accelerated, leading to upgraded implant stability and, ultimately, a longer-lasting solution.
