Quality Assurance of Dental Implants

Manufacturers of dental implants are confronted with high quality standards and strict regulatory requirements with regard to the safety of their products.During production, each implant must be inspected using a reliable process to make sure it complies with the tightest of tolerances and product liability requirements. This includes in-depth documentation of the production process along with secure, tamper proof storage of the measurement results.

Multi-part endosseous dental implants consist of three components. The threaded implant body replaces the tooth’s root and is firmly anchored in the jaw bone. The implant abutment functions as a connecting link between the implant body and the dental prosthesis, such as a crown or bridge. A fixing screw ensures the friction-locked connection of the abutment to the inner cone of the implant body with the dentures either screwed on or firmly cemented to the abutment.

Accuracy is the Key to Reliability
Production precision determines the fit accuracy and long-term stability of the implant system. The inner connection between the implant body and the abutment is particularly important. What characterises this connection design is the conical sealing fit between the two implant components with an inner hexagon which prevents rotation.A coordinate measuring machine(CMM) such as the Optiv Performance 443 from Hexagon Manufacturing Intelligence offers both economic and process-related advantages for meeting the needs of the measuring task. This coordinate measuring solution enables tight-tolerance geometries and form features of the prosthetic interface to be measured to a high resolution.The addition of clamping equipment custom made for each customer ensures the repeatable and stable fixturing of workpieces for measurement.

Ensuring a Secure and Optimised Measurement Process
The form deviation of the abutment outer cone and the inner cone of the implant body is determined through tactile scanning along with the surface form deviation of the inner hexagon. However, the overall size of the inner hexagon,along withthe easier-to-access outer cone angle of the abutment,can be measured optically, optimising the speed of the overall inspection process.

The Optiv Performance 443 also offers the option for tamperproof electronic documentation of the entire inspection process. This enables the automatic creation and archiving of measurement reports with a high degree of data security.By removing the need for physical, printed copies whilst increasing process reliability,manufacturers can ensure the complete traceability of each individual implant as required by international regulatory authorities.