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KMID : 0362220100370020121
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Journal of The Korean Research Society for Dental Materials
2010 Volume.37 No. 2 p.121 ~ p.132
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Development of KFDA standards for dental ceramics
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Shin Chae-Min
Lee Jung-Yeon
Bang Ji-Young
Choi Jae-Yoon
Lee Sang-Bae
Lim Kyung-Mi
Bae Woo-Jin
Roh Hye-Won
Oh Hyeon-Joo
Oh Heon-Jin
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Abstract
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Many kinds of dental ceramics have been used in the clinical dentistry as well as many new dental ceramic products have been introduced recently. If physico-chemical characteristics, performances and biocompatibilities of these products are not evaluated properly, it may cause multiple side effects. None the less the existing standards does not reflect current tendency in comparison with national standards and documentary. So it is necessary to prepare a revised standards of dental ceramics that is applicable to the evaluation of safety and effectiveness of dental ceramics by analyzing related national standards and documentaries and carrying out related evaluation test. Consequently, to provide a revised standards of dental ceramics that will be a foundation for evaluation of physico-chemical characteristic, performance and biocompatibility of dental ceramics, In this study we carried out all-inclusive analysis as to national standards(for example, KS, ISO, ANSI and so on) of dental ceramics and documentaries for present status of dental ceramics. And by the use of the result of above survey we conducted various tests like as chemical solubility, glass transition temperature, coefficient of thermal expansion, flexural test, cytotoxicity test and pyrogen test. In conclusion we could verify above national standards and test methods and then could suggest revised KFDA standards of dental ceramics.
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KEYWORD
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dental ceramics, medical device, standard
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