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2. Composition of the medical product 2.1. Material/indication group: Bioactive, bioresorbable bone replacement material for the replacement of hard tissue.

BioResorb® Classic and Macro Pore Instructions for Use

2.2 Effective components according to type and quantity: Bioresorb Classic and Macro Pore consists of pure ß-Tricalcium Phos- phate with the chemical formula Ca3(PO4)2 according to the precision of X-ray diffractometry. The analytic composition of Bioresorb Classic and Macro Pore are as follows (in mass-%): Calcium oxide Ca0 52.0 - 54.2 45.8 - 48.0 Phosphor pentoxide P2O5 3. Fields of application Bioresorb Classic and Macro Pore granules serve to augment mechanically unaffected, pathologic or traumatic bone defects caused by surgery. The site to be augmented must be free from infection and free from soft or granulation tissue. If a sceletal region with load transmitting function is concerned (e.g. mandible), the defect can be filled with Bioresorb Classic or Macro Pore granules only, or preferably with a mixture of autogenous bone (max. 50:50), so the biomechanical stability of the bone site is guaranteed despite the augmentation. Additional therapy for load adsorption (such as osteosynthesis) is indicated if the bone does not comply with the required biomechanical function. Indications in defect therapy and oral/maxillofacial surgery: • Defects after extirpation of bone cysts • Defects in corrective osteotomy • Other multiple walled alveolar bone defects • Periodontal defects, also in conjunction with membranes • Defects after extraction of impacted teeth • Defects after apicotomy • Extraction defects for implant therapy • Sinus floor elevation surgery • Peri-implant defects • Defects after harvesting of autogenous bone

Bioresorb Classic is available as follows: Korngröße Packungsgröße 500-1000 µm 0.5 g, 1.0 g 1000-2000 µm 0.5 g, 1.0 g 10. Application Bioresorb Classic and Macro Pore should be used only by a dentist or physician who is familar with oral implantology and augmentation techniques. lt is recommended to use the granuIes in a moist state. The mass of the individual granuIes adheres and allows an easier application into the defect than in dry state. For moistening, a sterile isotonic saline solution can be used, or autogenous blood of the patient or blood plasma (PRP – platelet rich plasma). If there is a risk of infection, combine with antibiotics. If the defect is larger than 2 cm3, we recommend to use a mixture of Bioresorb Classic or Macro Pore with autogenous bone if harvesting is anatomically possible. When applying the material, do not compress to save the interconnecting porosity, but spread evenly in the defect and fill completely. The granule sizes to be used is depending on the size of the defect. In general, the larger the defect, the larger the granule size. 0nce the bone defect has been densely filled up to the edges by using a spoon or spatula – depending on the size – the site is closed using the usual suture technique. The covering gingiva periost flap should achieve primary closure without tension so that no granules can be washed out. If primary closure is not possible, we recommend the use of a non-resorbable membrane Cytoplast Non Resorb, according to the situation and following the instructions for use for membrane technique. The augmented site should not be loaded during the initial healing phase (i.e. do not use temporary prostheses etc.). 11. Dosage The dosage depends on the granule size to be applied and the size of the defect. The defect should be completely filled.

5. Side effects Side effects related to the material are not known.

12. Pharmacological properties Bioresorb Classic and Macro Pore are a bioresorbable bone replacement material of pure ß- Tricalcium Phosphate with interconnecting porosity. The Calcium/phosphor atom ratio is 1.5 which is very similar to the mineral phase of the human natural bone of 1.6. The bioresorption, i.e. the resorption of Bioresorb Classic and Macro Pore, takes place according to the general principles for ceramic bone replacement materials:

6. Interaction with other substances lnteraction with other substances are not known.

• physico chemical solubility • direct cellular attack.

7. Warning instructions Do not augment in acutely infected regions, these have to be treated prior to augmentation. Caution with strong nicotine abuse.

Bioresorb Classic and Macro Pore are sintered by a special process with the favorable effect that the physico chemical decomposition into calcium and phosphate ions and the cellular attack occur parallel in a biocompatible way so that a quick bioresorption is achieved without complications. When using the micro and macroporous Bioresorb Macro Pore, the micro pores create a high capillary effect. The size of the macro pores allow the

4. Contraindications All diseases or therapies detrimental to the healing process, e.g. diabetes mellitus, treatment with glucocorticoids and antineoplastics or radiotherapy with gamma-rays (infected areas).

8. Incompatibilities Not known.

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9. Packaging Bioresorb Macro Pore is available as follows: Granule sizes Packaging sizes 200- 500 µm 0.5 ml 500- 1000 µm 0.5 ml, 1.0 ml, 2.0 ml 1000- 2000 µm 0.5 ml, 1.0 ml, 2.0 ml 1400-3200 µm 1.0 ml, 2.0 ml

entrance of osteoblasts and blood vessels. This guarantees a quick interconnecting growth of new bone substance, and the resorption of the bone material is enhanced from in between the granules. The polygonal granule shapes support the application into the defect by building an agglomerate with irregularly distributed but connected interspaces, with the property of osteoconductivity. Another advantage of using Bioresorb Macro Pore is: With reference to a same size defect volume, the human body (based on a porosity of more than 50% of the bone replacement material) only has to resorb approx. half of the applied volume of biomaterial. The material influences and accelerates the resorption process and offers new possibilities for the augmentation of large bone defects. The resorption of Bioresorb Classic and Macro Pore leads to exclusive products which are property of the body fluids (calcium ions, phosophate ions) and are not exceeding their physiologic variability during the course of bioresorption. New bone growth and resorption of the granuIes occur parallel proportional, i.e. while new bone forms within the defect, the bone replacement material is at the same time resorbed. According to the granule size, the resorption process should normally be concluded after 9 to 12 months (with Bioresorb Macro Pore and after 9 – 15 months with Bioresorb Classic), depending on the regeneration dynamic of the patient. The completed resorption is detectable by radiograph control for the purpose of implant insertion. 13. Miscellaneous Bioresorb Classic and Macro Pore are gamma sterilized and intended for single application. 14. Storage life Unopened undamaged packages will keep until the expiry date on the label. Do not use after expiration. 15. Special storage instructions Bioresorb Classic and Macro Pore are to be stored in unopened original package at room temperature. 16. Release date of the information January 2007

BIOVISION GmbH Am Vogelherd 52 D -98693 Ilmenau Exclusive Distribution Implant Direct Sybron International 27030 Malibu Hills Road · Calabasas Hills, CA 91301 · USA Phone +1 818 444 3300 · Fax +1 818 444 3401 ·

07-0112rB: 0811

1. Trade name of the medical product Bioresorb Classic and Macro Pore

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IFU - BioResorb  

BioResorb® Instructions for Use

IFU - BioResorb  

BioResorb® Instructions for Use