The Osteograft product world
In Germany, allogeneic cell and tissue transplants are regulated and subject to approval as medicinal products, which means that their production, biological safety and clinical use are subject to constant monitoring by the German authorities. The DIZG has 10 marketing authorizations for human tissue transplants.
Allogeneic transplants
The system for ensuring the biological safety of DIZG tissue transplants consists of extensive criteria for donor selection, comprehensive serological donor screening that far exceeds the requirements of EU Directive 23/2004 and includes 4 virus genome examinations, the use of a validated procedure for the removal/inactivation of viruses, bacteria and fungi, and in-process and final checks on the transplant.
The DIZG and ARGON are certified according to DIN EN ISO 13485 and follow the Ethical Code and the quality standards of the European Association of Tissue Banks (EATB).
The use of DIZG transplants is subject to documentation in accordance with the Transplantation Act (TPG).
For this purpose, labels for the patient file are enclosed with each package.
All dimensions are approximate and minimum values. They are subject to variation depending on the preparation and tissue. Explanations and instructions for the application of the transplants can be found in the instructions for use and technical information enclosed with each package.
The non-profit DIZG - German Institute for Cell and Tissue Replacement
In 1993, the Institute was founded by a dedicated group of doctors and scientists based on the extensive professional experience of the tissue banks at the University of Leipzig and the Charité University Hospital in Berlin. Their common goal was to build a bridge between donors and patients and to make the valuable gift of tissue donation accessible to the entire medical community.
With an unwavering commitment to outstanding safety and quality standards, the Institute has achieved an impressive record: over 500,000 human transplants have been procured by doctors and clinics both at home and abroad. These transplants have not only saved and improved the lives of countless patients, but have also made a significant contribution to the advancement of medical practice and research. Through continuous innovation and partnerships, the Institute continues its journey to push the boundaries of medical possibilities and shape a better future for patients worldwide.
Quality & safety
In Germany, allogeneic cell and tissue transplants are classified as medicinal products and are therefore subject to strict regulation and licensing requirements. This means that their production, biological safety and clinical use are subject to continuous monitoring by the German authorities. The German Institute for Cell and Tissue Replacement (DIZG) holds an impressive 10 marketing authorizations for human tissue transplants.
The system for ensuring the biological safety of DIZG tissue transplants is extremely comprehensive. It includes detailed criteria for the selection of donors as well as extensive serological donor screening that far exceeds the requirements of EU Directive 23/2004. This screening even includes four virus genome examinations. In addition, a validated process for the removal/inactivation of viruses, bacteria and fungi is used to ensure the safety of the transplants. In-process and final checks are carried out on the transplant both during the manufacturing process and before use to ensure the highest quality.
Both DIZG and ARGON are certified in accordance with DIN EN ISO 13485 and follow the Ethical Code and the quality standards of the European Association of Tissue Banks (EATB). These certifications and standards underline the commitment of both organizations to safety, quality and ethics in the field of tissue transplantation.
Applications/indication
Allogeneic tissue grafts play a crucial role in a wide range of dental procedures, including Class I to III, hemisection, furcation, apicoectomy, extraction, wisdom tooth removal, sinus lift, implantation and augmentation. Their primary area of application is in filling defects in oral and maxillofacial surgery, particularly in special indications where they are increasingly being chosen as the most effective material.
The use of DBM Pastös/Putty and DBM X-press Mix, which are immediately ready for use thanks to sodium hyaluronate, has proven to be extremely advantageous. In contrast, other materials require rehydration with a suitable sterile physiological medium before use. OsteoGel has proven to be the ideal carrier material. OsteoGel consists of a solution of sodium hyaluronate and plasma membrane proteins, which promotes optimal osteogenesis. The crucial role of sodium hyaluronate in cell proliferation, migration and adhesion underlines its importance for the success of the transplantation.
The use of allogeneic tissue grafts opens up a wide range of benefits, especially in challenging procedures such as sinus lift and augmentation. With their increasing acceptance and proven efficacy, they are becoming an essential resource for modern dental practice, with the potential to optimize treatment outcomes and significantly improve patient recovery.
Allogeneic tissue grafts offer a number of advantages, including their versatility in various dental procedures and their proven effectiveness in filling defects in the oral and maxillofacial region. They have proven to be particularly useful in complex procedures such as sinus lift and augmentation, allowing for more stable and sustainable tissue regeneration.
Due to their increasing popularity in dental practice and their documented effectiveness, allogeneic tissue transplants are becoming an indispensable part of the treatment spectrum. Their use not only leads to improved treatment outcomes, but also offers patients a faster recovery and a better quality of life after surgery. This underlines their importance as a key component of modern dental care and their ability to continuously improve standards of patient care.
Quickfinder products:
Granules
Mineralized collagen-bone matrix granules with 10% mineral content offer variable service life and are not radiopaque. Approved under the German Medicines Act, they consist of corticospongious bone in various grain sizes, which simplifies their handling.
Blocks & chips
Human blocks and chips are versatile in implantology. They serve as a basis for the bone ring technique and as an alternative defect filling. They enable fast reconstruction times thanks to their rapid revascularization and offer ideal primary stability for single-stage implant placement.
Demineralized bone matrix (DBM) pasty
Demineralized bone matrix (DBM) in paste form is a pioneering product for augmentation. It promotes bone growth and healing, improves bone quality and optimizes surgical results.
Membranes
Membranes are important tools in regenerative medicine, especially in oral and maxillofacial surgery, for soft tissue regeneration and as connective tissue grafts. Rehydrated before use, products such as OsteoGel promote osteogenesis.
Osteogel
High-precision, modular systems that can be customized according to your requirements and the thread designs and lengths you use, but in one place!