US implants TM Bauer`s Implants have been tested in European laboratories, confirming their quality and safety
Bauer`s Implants, manufactured by ABM Technology plant in Dnipro, will soon appear on the US and Europe market. For the last six months, Bauer`s Implants have been undergoing preclinical tests in laboratories in USA and Europe. Now all studies have already been completed and Bauer`s Implants TM has received results confirming the quality and safety of the product.
Fatigue test proven Bauer`s Implants lifetime warranty
The German laboratory EndoLab carried out a dynamic and static stress test in accordance with the international standard ISO 14801: 2016 "Dentistry - Fatigue test for endosseous dental implants". The purpose of the test is to find out whether the implants will withstand the number of chewing movements that a person makes in a lifetime.
The stability of the implants was tested by special machines that perform 5 million cycles per month (the approximate number of chewing movements performed by a person throughout his life).
Each implant was fixed in a shape made of a material similar in its characteristics to human bone tissue, 3 mm below the level of the upper surface. The mold with the implant was fixed in an aluminum holder with a 35° tilt. All tests were carried out at room temperature. The load was directly applied to the hemispherical apex in accordance with ISO 14801 using a 60 mm pusher, which was supported by a steel ball to load the abutment.
Bauer`s Implants withstood all 5 million cycles with a force of 175 N. For comparison, when chewing crackers and biscuits, 39-146 N are required, and carrots - 118-134 N.
“The dynamic stress test has confirmed that Bauer`s Implants have a lifetime warranty. At the same time, a person will be able to eat any food” said Elena Konyakhina, Deputy Director for Quality at ABM Technology.
World-Implant also underwent a static test, in which the implants were loaded until a fracture occurred when the sample reached its maximum load. In a static test, World-Implant withstood a force of 416 N.
Electron microscopy of the surface by scanning has proven the porosity and cleanliness of the surface of Bauer`s Implants
Surface electron microscopy by scanning (Scanning electron microscopy (SEM)) and energy dispersive X-ray spectroscopy (EDX) were performed by SGS laboratory in Germany.
As a result of this test, photographs of the surface were obtained at a magnification of 500, 1000, 1500, 2000, 2500, 5000, 7500 and 10,000 times.
Electron microscopy has proven that the surface of the implant is perfectly clean. In addition, the study recorded the presence of porosity, which is most favorable for rapid osseointegration of the implant.
The X-ray spectrum from the analysis area confirmed the absence of impurities and contaminants.
Bauer`s Implants TM are ready to launch a high-quality and safe product on the market
The goal of Bauer`s Implants TM is to release a product with a lifetime guarantee of sustainability and quality. Therefore, the plant is guided not only by international standards and Technical Regulations, but also by high internal requirements of quality management.
“Our main goal is to launch a high-quality and safe product on the market, because we care about our future partners and the health of their patients” said Elena Konyakhina, Deputy Director for Quality at ABM Technology.