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医薬品医療機器等法(薬機法)に
関する記載事項
インビザライン完成物は、日本国内において薬機法未承認の矯正装置であり、医薬品副作用被害救済制度の対象外となる場合があります。尚、インビザラインの材料自体は、日本の薬事認証を得ています。
「インビザライン」は米国アライン・テクノロジー社の製品の商標で あり、インビザライン・ジャパン社から入手しています。
日本国内においては、同様の医療機器が薬事認証を得ています。
インビザライン・システムは、世界100カ国以上の国々で提供され、これまでに1200万人を超える患者様が治療を受けています。(2022年12月時点)
相談だけでも可能です!
お気軽にお問い合わせください。
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