Animal origin
Raw materials are sourced from certified suppliers, where animals are checked by the local Veterinary Service. Furthermore, the OsteoBiol® product line is free from Taenia solium eggs/larvae since Tecnoss® processes only bone and mesenchymal tissue, whereas striated muscles from the heart, tongue, and intercostal muscles are reservoirs of the aforementioned parasites.
OsteoBiol® heterologous collagenic biomaterials are porcine and equine xenografts. For this reason, they are free from BSE (Bovine Spongiform Encephalopathy) and TSE (Transmissible Spongiform Encephalopathy) diseases.
Finally, OsteoBiol® heterologous collagenic biomaterials are classified as “tissues with no detectable infectivity” (UNI EN ISO 22442-1, and UNI EN ISO 22442-3).
Our product line is CE certified, and the conformity is annually checked by Notified Bodies.
The Product safety is also guaranteed by the Tecnoss® risk (ISO 14971) and quality management system (UNI EN ISO 13485).
Our product line is compliant with the high-quality standards of biocompatibility (ISO 10993).
Our product line is sterilised by gamma rays, according to international standard procedures (UNI EN ISO 11137-1, UNI EN ISO 11137-2, and UNI EN 556-1).
Tecnoss proactively undergoes extensive post-marketing surveillance activities to check the clinical performance of its Class III Medical Devices, in order to guarantee the highest quality and safety standards to oral surgeons and patients.
Safety and performance
More than 2 million surgeries, 350 scientific papers, zero product recalls, and more than 25 years of clinical experience demonstrate that the OsteoBiol® product line is safe and trustworthy.
In addition, according to the Italian Ministry of Health, patients who underwent surgeries with OsteoBiol® by Tecnoss® Class III Medical Devices can continue to donate blood and blood components, subject to the temporary suspension measures applied in relation to surgery, as set out in current legislation with regard to transfusions.