BEGO Semados® implants are fabricated under strict conditions in the modernised clean room, and then immediately packaged in the low-germ, low-particulate environment. The core process is the subtractive finishing of the implant blank through various treatment steps to produce a defined roughening of the surface, ensuring the best osseointegration possible. The quality features include the defined, homogeneously distributed surface roughness and its purity.
The fabrication and processing of dental implants demands high purity standards which BEGO Implant Systems, certified to ISO 9001, MPG ISO 13485 and the Directive 93/42/EEC, goes a long way to satisfy. The clean rooms can only be accessed by specially trained staff via an airlock and, after surface finishing, the products go directly via a separate airlock system to the clean rooms compliant with ISO 14644, CL. 7 / EG GMP C where they are fine-cleaned and undergo a final video microscope examination before being packaged under clean, low-germ conditions.
All implant systems in the BEGO Semados® product range feature the proven TiPurePlus surface, with the exception of the provisional PI-Line. This entails sandblasting and etching the implant blank, which is made of Grade 4 commercially pure titanium, using a special, precisely defined technology.
The purity of this surface sets new standards . Surface residues from the blasting and etching process are not detectable. Moreover, the homogeneous surface has a very high protein-binding capacity, which has a positive effect on the healing time of implants.
Within the framework of long-term monitoring, the survival times of Semados® implants were determined in accordance with Kaplan and Meier’s method and compared with the data from other long-term studies. The survival probability shows that the implant system is comparable to other systems with regard to the prognoses described in the literature, and that it may be expected to survive equally as long .
- Duddeck D. and Neugebauer J., Surface analysis of sterile-packaged implants, Implantologie Journal 2015, 19:28-32
- Fenske C. and Sadat-Khonsari MR., Implant prognosis of 601 Semados® implants, Implantologie 2007, 15:47-50