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J Korean Assoc Oral Maxillofac Surg. 2019 Apr;45(2):51-67. English. Review. https://doi.org/10.5125/jkaoms.2019.45.2.51
Ku JK , Hong I , Lee BK , Yun PY , Lee JK .
Department of Oral and Maxillofacial Surgery, Asan Medical Center, Seoul, Korea.
Department of Oral and Maxillofacial Surgery, Section of Dentistry, Armed Forces Capital Hospital, Seongnam, Korea.
Department of Oral and Maxillofacial Surgery, School of Dentistry and Institute of Oral Bioscience, Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Chonbuk National University, Jeonju, Korea.
Department of Oral and Maxillofacial Surgery, Institute of Oral Health Science, Ajou University School of Medicine, Suwon, Korea. arcady@ajou.ac.kr
Abstract

As dental implant surgery and bone grafts were widely operated in Korean dentist, many bone substitutes are commercially available, currently. For commercially used in Korea, all bone substitutes are firstly evaluated by the Ministry of Health and Welfare (MOHW) for safety and efficacy of the product. After being priced, classified, and registration by the Health Insurance Review and Assessment Service (HIRA), the post-application management is obligatory for the manufacturer (or representative importer) to receive a certificate of Good Manufacturing Practice by Ministry of Food and Drug Safety. Currently, bone substitutes are broadly classified into C group (bone union and fracture fixation), T group (human tissue), L group (general and dental material) and non-insurance material group in MOHW notification No. 2018-248. Among them, bone substitutes classified as dental materials (L7) are divided as xenograft and alloplastic bone graft. The purpose of this paper is to analyze alloplastic bone substitutes of 37 products in MOHW notification No. 2018-248 and to evaluate the reference level based on the ISI Web of Knowledge, PubMed, EMBASE (1980–2019), Cochrane Database, and Google Scholar using the criteria of registered or trademarked product name.

Copyright © 2019. Korean Association of Medical Journal Editors.