GDT Implants Complies With High-Quality Control Standards:
Each product is created with special care and attention. Our dedication to excellence is reinforced by continuous and systematic quality control processes that adhere to international standards.
Rest assured, our products undergo rigorous scrutiny to ensure their reliability and performance.
We embrace cutting-edge, high-tech equipment during the production process, pushing the limits of innovation. Our aim is to deliver products that seamlessly integrate with the needs of our valued customers and their patients.
By leveraging the latest advancements, we strive to provide solutions that are not only fitting, but also highly useful.
We adhere to international standards, meticulously meeting the requirements of EN: ISO 13485:2003
and ISO 9001:2008.
Additionally, our products bear the CE mark, indicating compliance with European regulations, and are FDA approved, demonstrating our commitment to meeting the highest quality standards worldwide.
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.
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).
The cutting-edge 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.
RBM
Resorbable Blast Media
Renowned for its rough and hydrophilic properties. This innovative technique is meticulously designed to create a textured implant surface without leaving any residual embedded blast particles or debris in the treated substrate.
The RBM process involves blasting the implant with carefully chosen hardened particles of Hydroxyapatite (beta-tricalcium Phosphate, Alpha Tcp, TTcp, and Calcium Phosphate (CPP)). These particles work harmoniously to achieve the desired roughening effect. Subsequently, a well-defined passivation treatment dissolves these particles from the surface, leaving behind the desired result.
Consistently achieving a surface roughness between
Ra 1.2 - 1.5, RBM offers a rougher implant surface compared to traditional acid etching methods.
This enhanced roughness provides numerous benefits, including a greater surface area for osseointegration, improved retention characteristics, increased biological fixation, and optimized implant-to-bone contact.
Multi-Stage Cleaning Process
Ensures a Contamination-Free Surface.
Successful dental implantation relies heavily on the material composition and surface cleanliness of the implants.
To ensure a clean surface, a thorough cleaning process is carried out at multiple levels, effectively removing any contaminants that may arise during manufacturing.
This accurate cleaning procedure not only achieves a perfectly clean surface but also creates a stable oxide film layer on the titanium alloy surface.
This layer acts as a passivation barrier, measuring only 3-5 nm in thickness, and does not conceal the microtopography.
As a result, the body’s cells can freely utilize the surface as a substrate, crucial for the successful integration of the implant.
An exceptional method, inspired by protocols and standards used in the production of semiconductor electronic components.
This method ensures a perfectly clean surface, enhancing the overall quality of GDT Implants.
The effectiveness of these technologies has been verified through detailed analysis of the material’s surface and chemical composition.
X-ray photoelectron spectroscopy and scanning electron microscopy were employed, using magnifications of 50x for an initial evaluation of surface cleanliness, as well as 1000x and 5000x for a detailed analysis of the microstructure.
Additionally, energy-dispersive X-ray spectroscopy wasutilized to further assess the composition of the implants.
