Keywords
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Keywords
Moldble allogeneic bone grafting materialNon-paying medical devicesNo need for tissue transplant resultsUse raw materials based on AATB
Technical Data
Major bone augmentation/54Y/F, Mandibular right #2 premolar & #1 molar reconstruction
Minor bone augmentation/66Y/M, Maxillary anterior fenestration dehiscence augment
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Intended Use
This product is a bone graft material intended for use in the restoration of alveolar bone defects. It is used to supplement deficient bone tissue and to promote bone regeneration at bone defect sites.
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Preoperative Preparation
1) This product is supplied sterile and its sterility must be maintained. Opening of the package and preparation for the procedure shall be performed in a clean, hygienically controlled clinical environment.
2) Do not use the product if the inner packaging is torn, opened, or shows any visible signs of damage.
3) Do not use the product beyond its expiration date.
4) Prior to use, qualified healthcare professionals shall carefully read these Instructions for Use and fully understand the product characteristics and intended method of use in accordance with applicable regulations.
5) Prior to the procedure, qualified healthcare professionals shall review the patient's medical history and confirm the absence of any known allergy or hypersensitivity to the product components in accordance with applicable regulations.
6) To minimize the risk of infection at the treatment site, all surgical instruments that come into contact with this product or are used during the procedure must be sterile. -
Directions for Use
1) Expose the alveolar bone defect site and thoroughly remove all granulation tissue, inflammatory tissue, and other soft tissues.
2) Before using this product, identify the surgical site to be grafted and thoroughly irrigate the area with sterile water or normal saline.
3) Open and use an appropriate amount of the product according to the treatment site. Since sterility cannot be guaranteed once the package has been opened, the entire contents should be used immediately after opening, and any remaining material must be discarded.
4) As this product is supplied sterile, open the container immediately before use and transfer the contents to a sterile container.
5) Before use, verify the appropriate hydration volume according to the amount of the product, and adequately hydrate the product using sterile normal saline or the patient's blood.
6) Apply the product to the target site, contouring it carefully to ensure intimate adaptation and seamless contact with the defect walls.
7) To prevent graft migration from the treatment site, cover the graft with a barrier membrane and/or securely suture the surrounding soft tissue as necessary.
8) It is recommended to use the product immediately after hydration. -
Storage and Expiration date
Store at room temperature (1–30°C). Avoid direct sunlight and storage in hot or humid environments.
This product is intended for single use only. Any unused remaining material shall be discarded immediately following biomedical waste regulations and must not be reused.
The shelf life of this product is 3 years from the date of manufacture (please refer to the packaging for details). -
Precautions
1) This product is a sterile, single-use medical device and must not be reused.
2) Do not use the product after its expiration date.
3) This product shall be used only by qualified and appropriately trained dentists or other licensed healthcare professionals with relevant expertise.
Manufacturer
MedPark Co., Ltd.|#1007, #1009, ACE High-Tech City 2, 25 Seonyu-ro 13-gil, Yeongdeungpo-gu, Seoul, Republic of Korea | TEL: +82-2-554-8776
Sepcifications