MegaBone Oss®
MegaBone Oss®
Medical Device
| Principle of action |
This product is created by mixing human cortical and cancellous bone powder and hyaluronic acid (HA). Here, sodium hyaluronate serves as a carrier for applying bone powder to the implant site. The finished product, which has been formulated, is implanted in the area of the alveolar bone defect to fill and replace the area of the bone defect and induce bone formation. |
| Purpose of use |
This product is a dental bone graft material manufactured by using two or more materials in combination and used to fill and replace the area of an alveolar bone defect. |
| Storage method and Shelf life |
Room temperature (1~30’C), 3 years from the date of manufacture |
| Precautions for use |
A. Warning N/A B. Precautions regarding age, gender, or health condition for use in consideration of the characteristics of medical devices It should not be used if there is a possibility that the patient may cause side effects. It should not be used if the patient to be transplanted has an allergic reaction to the reagents and solutions used in the preparation of this product prior to transplantation. It should not be used if there is a possibility that the patient may cause an adverse reaction. This is especially careful for immunocompromised patients. C. Adverse reactions that may occur as a result of using medical devices Precautions regarding fatal side effects and accidents caused by negligence in use. 1) If the opened product is left in a contaminated or non-sterile state before transplantation to the patient, the product must not be injected into the patient, and it must be returned to L&C BIO or disposed of properly as medical waste. 2) Before use, be sure to check whether the recipient has an allergic reaction to the reagents and solutions used in the manufacture of this product. 3) This product must be used within the expiration date indicated on the product label, and if the product has passed, you must contact L&C Bio for a return or exchange. 4) Store this product in a cool, dry place, avoiding direct sunlight, in accordance with the storage conditions suggested by the company. Do not use products outside of the storage conditions presented. 5) This product should be operated on patients who do not have inflammation at the transplant site according to contraindications and precautions. D. General notices 1) Before using this product, you must read all instructions for use and precautions for use. If the instructions for use and precautions for use are not followed properly, the product may not perform properly or may cause infection or side effects. 2) This product is a product for patient treatment and must be used by medical professionals, and use other than the intended use is prohibited. 3) If any breakage or damage to the packaging is found before using the product, the product must not be transplanted, and immediately after discovery, it must be returned or exchanged by contacting L&C Bio. 4) If side effects are discovered in the transplanted patient, immediately report it to the Ministry of Food and Drug Safety, and the hospital and doctor who performed the transplant take necessary medical measures for the patient. E. Interaction N/A F. Use for pregnant women, lactating women, childbearing women, newborns, infants, children, the elderly 1) There are no clinical data for this product for pregnant women or women of childbearing potential and lactating women. Therefore, its use is not recommended for safety reasons. 2) Since clinical trials have not been conducted on the safety and efficacy of this product in children with underdeveloped skeletal development, its use is not recommended. G. Notices in application 1) This product is gamma-ray sterilized and must not be re-sterilized, and even once opened, the product must not be re-sterilized and reused. 2) Each individually packaged product is intended for use on only one patient. H. Requirements for prevention of accidents 1) Since this product is manufactured through a GMP process certified by the Ministry of Food and Drug Safety, it is recommended to use this product in an environment (sterile environment) and facilities similar to the manufacturing environment when using this product. 2) The affected area where the transplantation takes place shall be kept non-contaminated. |
