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Bone graft materials and its intended use

Other Title
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Authors
이, 정근
Citation
Taehan Ch'ikkwa Uisa Hyophoe chi, 48(4):256-262, 2010
Journal Title
Taehan Ch'ikkwa Uisa Hyophoe chi; Daihan c̆igwa üisa hyebhoi-ji; Journal of the Korean Dental Association; 대한치과의사협회지
ISSN
0376-4672
Abstract
bone grafting is indicated in the case of bony defects and is classified into autograft, allograft, and xenograft. Synthetic bone graft is contrasted with these three categories in that it has a different donor source. Autograft is most prominent as it is known as a gold standard of all grafting procedures. Its principles and practices are well established via accumulated informations and clinical experiences, which imposes no regulations or restrictions in its clinical use. On the other hand, other bone graft procedures are under tight control for the safety and effectiveness of each product.

Food and Drug Administration of the United States has a system in which the information on the approvals and clearances of bone graft materials on their internet homepage. All the bone graft materials that are under the regulations of the United States are classified into the category of medical devices, which includes allogenic bone, xenogenic bone, and synthetic bone graft materials. Each bone graft material has its own indication and the FDA approvals and clearances of medical devices contain the item of “intended use”to specify the indications of each bone graft materials. US dentists, as users of the specific bone graft materials, areprovided with adequate information on the approved materials they are to utilize.

As an user of these materials, Korean dentists are less provided with the information on the bone graft materials they want to use. Medical providers of the bone graft materials have to be able to provide their users with the essential information such as the intended use of the regulatory approval. Dentists must also be active in gathering informations on the material of their interest, and the system must be built in which both of the medical providers and users of bone graft materials can be satisfied in providing and getting the information, respectively.
Keywords
Bone graft materialsBone biologyApprovals and clearances
Appears in Collections:
Journal Papers > School of Medicine / Graduate School of Medicine > Dentistry
AJOU Authors
이, 정근
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