J Korean Assoc Oral Maxillofac Surg 2019; 45(2): 51~67
Dental alloplastic bone substitutes currently available in Korea
Jeong-Kui Ku1,2, Inseok Hong3, Bu-Kyu Lee1, Pil-Young Yun2, Jeong Keun Lee4
1Department of Oral and Maxillofacial Surgery, Asan Medical Center, Seoul, 2Department of Oral and Maxillofacial Surgery, Section of Dentistry, Armed Forces Capital Hospital, Seongnam, 3Department 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, 4Department of Oral and Maxillofacial Surgery, Institute of Oral Health Science, Ajou University School of Medicine, Suwon, Korea
Jeong Keun Lee
Department of Oral and Maxillofacial Surgery, Institute of Oral Health Science, Ajou University School of Medicine, 164 WorldCup-ro, Yeongtong-gu, Suwon 16499, Korea, TEL: +82-31-219-5333 FAX: +82-31-219-5329, E-mail: arcady@ajou.ac.kr
ORCID: https://orcid.org/0000-0002-5561-6297
Received March 24, 2019; Revised March 28, 2019; Accepted March 28, 2019.; Published online April 30, 2019.
© The Korean Association of Oral and Maxillofacial Surgeons.. All rights reserved.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
 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.
Keywords: Bone substitutes, Dental implantation, Korea


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30 April 2019
Vol. 45
No. 2 pp. 49~120

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