Manufacturers of dental implants are confronted with high quality standards and strict regulatory requirements with regard to the safety of their products. The manufacturing process must be reliable, and each implant is inspected to make sure it complies with the tightest of tolerances and product liability requirements. Our manufacturing and inspection procedures are continually monitored and the results documented.
The PYRAMIDION manufacturing facility uses an extremely clean water system with a maximal conductivity of 0.8 μ/S in order to clean the implants during the manufacturing process. The aspects of bioburden, sterility and bacterial presence are constantly monitored, which ensures a stable and valid cleaning process.
As proven by scientific research, implant surface directly affects osseointegration.
The Pyramidion implant system is made from titanium alloy, Grade 23, which meets the requirements of ASTM F-136, “Standard Specification for Wrought Ti-6AL-4V ELI Alloy for Surgical Implant Application”.
This alloy’s biocompatibility and ability to achieve close contact with human bone makes it ideal for dental implants.
The implant surface is blasted by TiO2 particles, etched under specific conditions, and undergoes an extensive cleaning process. This surface treatment creates four levels of interaction with the bone: macrostructures, micro- and nanotopography, and interactions on a molecular level.
Pyramidion quality system is ISO 13485 and ISO 9001 certified.
PYRAMIDION products hold FDA 510(k) clearance.
PYRAMIDION products comply with medical device directive 93/42/EEC and hold CE clearance.