DENTAL ALLLOGREFT
HUMAN BONE TISSUE
USE THE POWER OF THE CELL®
Atident is a first-class human-derived cancellous graft produced from the femoral heads. As demonstrated by international clinical studies, it is an allograft with superior properties that supports rapid formation of new alveolar bone tissue by inducing osteoblasts in the area of application.
ATİDENT CİPS ALLOGREFT
HUMAN SOURCED GROUND BONE
GRAFT
Atident Allograft Ground Bone Tissues;
Reconstructive jaw surgery, Sinus Lifting, Periimplantitis, Augmentation, Flap operations, Implant applications, Periodontal Defects, Socket filling etc. It is a premium grade graft used in various surgical procedures that require bone grafting for dental purposes.
The femoral heads of healthy bones obtained from living donors are processed with 100% safe, sterile and patented medical methods, ground and packaged with gamma irradiation.
Adopting the absolute assurance system, Atident offers each of its products insured against production-related complications
ATIDENT ALLLOGREFT CHIPS TYPES
ATIDENT CUBE BLOCK ALLLOGREFT
HUMAN SOURCED CUBE BLOCK BONE GRAFT
Atident Allograft Cube Block It is a first class graft shaped as a cube block used to help repair bone defects. It strongly supports the regeneration of bone tissue, allowing bone defects to be treated with surgical procedures. The femoral heads of healthy bones obtained from living donors are processed and sized with 100% safe, sterile and patented medical methods, and then packaged with gamma irradiation.
Adopting the absolute assurance system, Atident offers each of its products insured against production-related complications.
ATIDENT ALLOGRAFT CUBE BLOCK DIMENSIONS
In accordance with the relevant legislation of the Ministry of Health, Atident bone grafts are not subject to UTS'.
Atident ALLOGREFT
BONE CHIPS AND CUBES
Atigen-cell is an organization that provides bone cubes and chips from cancellous bone of the femoral head for clinical use by physicians.
The spongy bone cube and chip were sterilized. It was freeze-lyophilized to reduce the water content to Cube and chips are ready to use.
Differences in appearance and clinical efficacy of the product may be expected due to the presence of biological material.
These products; It is used in orthopedics, reconstructive jaw surgery and various surgical applications that require bone grafting. It can be used alone or in combination with other forms of autologous bone or bone graft. It is generally thought that the bone cube and chip act as a skeleton in bone formation. Bone formation; It depends on various factors such as patient factors, surgical trauma and product characteristics. Bone cubes and chips may have osteoconductive and osteoinductive properties. Whether or not these features are reflected in the clinical result, they vary according to the state of the biological process. Animal osteoinduction testing has not been performed on bone cubes and chips products, as it is not possible to fully demonstrate osteoconductive or osteoinductive properties in animals by osteoinduction in humans.
PRE-OPERATION PREPARATION
It is important to prepare the operation site for the application of the allograft. Before the application, the treatment area should be free of infection.
STORAGE CONDITIONS
Cubes and chips should be stored at room temperature, in a dry place away from direct sunlight. Products should not be frozen. It is the responsibility of the transplant center or the physician to keep the product in proper conditions until the user.
Cubes and chips are packaged in sterile bottles. The bottles are vacuum packed in PET/Alu bags. Both the cube and chips and the bottle are sterile. In inner packaging; donor information, production lot number, expiry date, product code and description and information showing the number of products are included. There is additional information on the outer packaging.
The following recommendations and procedures should be followed to get a good result and increase the chances of success:
Cubes and chips and vials containing them must be sterile.
For contamination products, all products must be preserved under aseptic conditions.
Allograft bone products opened under aseptic conditions should be used within 24 hours.
Cube and chips packages should be opened as follows:
The product should be opened according to aseptic/sterile procedures.
After the outer packaging is opened, the inner packaging should be taken to the sterile field.
The bottle must be opened after the inner packaging has been opened.
Chips
Can be soaked with a sterile solution before use.
Depending on the surgeon’s preference, antibiotics can be used with the solution. Before use, it should be checked whether the patient is sensitive to the antibiotic. The antibiotic concentration should be lower than normal IV administration.
It is recommended to use one solution for each product.
The chips: should be used within 2 hours after reconstitution
According to EU 2006/86 directives, tissue recipient records should be kept for 30 years to ensure post-transplant traceability. These records will not only enable traceability, but also make it easier for Atigen-cell to monitor real or suspected disease states. Monitoring report and affixable labels are included in each box. Serial number and texture information are on each label. Please write the patient information, the name and address of the transplanted hospital, allograft information and your comments on the use of the tissue (using removable barcode labels) on the Allograft Monitoring Report. Then send the tissue bank copy to the Atigen-cell address indicated on the form. The first copy of the Allograft Monitoring Report should be kept in the hospital for reference, and the patient copy should be given to the tissue recipient.
- European Union Directive 2004/23/EC and dated 31 March 2004
- European Union Directive 2006/17/EC dated 08 February 2006
- European Union Directive 2006/86/EC dated 24 October 2006
Proses ve ambalajlama işlemi kontrollü aseptik şartlarda, İyi İmalat Uygulamalarına (GMP) göre sınıflandırılmış B sınıf arka plan içinde A sınıf LAF kabinlerde yapılmıştır. Tüm aşamalar titizlikle kalite kontrole tabi tutulmuştur.
Küp ve çipsler sterilize edilmiş ve viral inaktivasyon için gama ışınlaması uygulanmıştır (25 kGy). Ürün tekrar sterilize edilmemelidir.
In line with EU 2004/23 directives and its EU 2006/17 and EU 2006/83 annexes, the medical and social history of the donor before donation was examined, and medical conditions and diseases that may contraindicate tissue donation were investigated.
The following tests were performed on blood samples taken from the donor during recovery:
If there is no sign of infection in the serological test findings, the allograft is considered suitable for transplantation.
Donor acceptance confirmation; The donor’s history, physical evaluation, current medical records, infection results, all information obtained from other sources regarding the donor’s suitability are given after evaluation by the physicians. Aerobic and anaerobic microbiological tests are performed to assess whether the tissue is contaminated. Donor information is stored in Atigen-cell records and protected for 35 years.
This tissue is suitable for transplantation. All donor screening, serological and microbiological testing procedures have been performed and verified according to EU 2004/23 directives and its EU 2006/17 and EU 2006/86 annexes.
“Atident is made from femur heads donated by living Turkish donors, ATİGEN-CELL BİYOTEKNOLOJİ A.Ş. It is the first and only Allograft produced by the lyophilization method by its laboratories.
Sterile and Virus Inactive Human Allograft Tissue
You can now order online for your implant graft, sinus lifting graft, dental graft, block graft, allograft, periodontal treatment grafts orders.
Surgical applications that need grafts
“Atident is made from femur heads donated by living Turkish donors, ATİGEN-CELL BİYOTEKNOLOJİ A.Ş. It is the first and only Allograft produced by the lyophilization method by its laboratories.”
Sterile And Virus Inactive Human Allograft Tissue
You can order online now for implant graft, sinus lifting graft, dental graft, block graft supply and your orders.
