Intertwined

Quality Assurance

GDT Implants Complies With High-Quality Control Standards:

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Products carry the CE mark that includes visits from the European Medical Device Directive (93/42/EEC)

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The major quality control system is in compliance with EN ISO 13485:2016 and FDA QSR 21 CFR Part 820

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The facilities are subject to routine inspection by international inspectors.

Each product is created with special care and attention.

GDT Implants conducts continuous and systematic quality control of all products which is confirmed by international quality standards.

We use the most advanced high-tech state-of-the-art equipment during production with the end goal of creating a fitting and useful product for our customers and patients.

GDT Implants quality assurance and regulatory systems comply with international quality standards, complying with EN: ISO 13485:2003 and ISO 9001:2008, CE marked and FDA approved.

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MATERIAL

GDT Implants are made of Titanium alloy Ti 6Al 4V ELI, a material that combines properties such as low specific weight, high strength to weight ratio, very high corrosion resistance, and excellent general biocompatibility.

Ti6Al4V ELI is very similar to Ti6Al4V, except that Ti6Al4V ELI contains reduced levels of oxygen, nitrogen, carbon, and iron.

ELI is short for “Extra Low Interstitials”, and these lower interstitials provide improved ductility and better fracture toughness for the material.

Ti 6Al 4V ELI has proven to be highly successful in the fabrication of dental implants.

Surface Treatment

SLA

Sandblast, Large grit, Acid-etch 

SLA is a type of surface treatment that creates surface roughness intending to enhance osseointegration through greater bone-to-implant contact (BIC). 
SLA surface treatment technology is based on a large-grit sandblasting technique that generates a macro-roughness on the titanium surface, This technique is followed by acid-etching that superposes a micro-roughness, This topography offers an excellent structure for cell attachment. SLA surface treatment increases the rate at which osseointegration occurs by using a combination of grit and acid etching to give the surface increased roughness on multiple levels. 
This allows osteoblasts to proliferate and adhere to the implant surface. 
Through osseointegration, SLA helps provide increased stability to the implant which will ultimately lengthen its longevity

RBM

Sandblast, Large grit, Acid-etch 

RBM surface is rough and hydrophilic. 
This surface treatment is designed to roughen the implant surface without leaving the residual embedded blast particles or debris in the treated substrate. 
To gain the desired roughening the implant is blasted with suitable hardened particles of Hydroxyapatite (beta-tricalcium Phosphate, Alpha Tcp, TTcp, and Calcium Phosphate (CPP) and then subsequently dissolved from the surface with a defined passivation treatment.
Surface roughness between Ra 1.2 - 1.5 is consistently achieved.
The result is a rougher implant surface than traditional acid etches treatment providing a greater surface area for osseointegration, improved retention characteristics, increased biological fixation, and maximizing implant-to-bone contact.

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Life-Time Warranty

GDT Implants provides a lifetime warranty for their implants and undertake the responsibility to replace, free of charge, any implant/abutment manufactured by GDT Implants.

The terms and conditions of these warranties are set out under the following conditions

 

FDA Certification

 
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