This explanation sheet describes the material characteristics of Bio-Oss® and Bio-Gide®.
Why is an Explanation Necessary?
Bio-Oss® Bone Replacement Material
What are the reasons for using Bio-Oss®?
What is Bio-Oss®?
Bio-Oss® is a bone replacement material that is used to increase the body’s own bone. Bio-Oss® is composed of the hard, mineral portion of natural bone and has a structure very similar to that of human bone. It is therefore well accepted by human bone tissue and serves as a guide-rail for the new bone growth.
The starting material is carefully inspected bovine bone that has undergone treatment with patented processes for purification and sterilisation. Included amongst these processes is the treatment of Bio-Oss® at high temperature for more than 15 hours, after which it is highly purified and finally sterilized.
In certain procedures, Bio-Oss® COLLAGEN is used for regenerating bone. This product is the same as the Bio-Oss® described above, but has highly purified natural collagen fibres added to it. The collagen is obtained from pigs.
What is the function of Bio-Oss®?
Bio-Oss® is a solid scaffold which serves as a guide-rail to allow new bone to grow. This scaffolding material enables and facilitates bone formation in the area where the operation is performed. It is inserted into the operation area in the form of grains or small blocks. Your own bone slowly grows into the Bio-Oss® material, which at a later time is gradually broken down by the body.
Are there alternatives?
There is now a second area of operation, which may be associated with additional pain or loss of sensitivity.
It is possible that the amount of the newly gathered bone will not be adequate for the intended purposes.
Bio-Gide® Collagen Membrane
What is Bio-Gide®?
What is the function of Bio-Gide®?
What is Bio-Gide made from?
Does the Bio-Gide® membrane have to be removed in a second procedure?
Are there any Independent Quality Controls?
The manufacturing processes of Bio-Oss® and Bio-Gide® are subject to a Quality Assurance System based on international guidelines (ISO 9001 / EN 46001). These processes are checked once every year by acknowledged, independent testing institutes and international authorities.
Bio-Oss® and Bio-Gide® are medical devices that satisfy the safety standards and conditions required by European Union (CE -Certification) and the US Food and Drug Administration (FDA).