登士柏西诺德生产的XiVE S系列纯钛植体，自2017年2月起 在中国注册为钛四级（TA4），但后经第三方检测，部分抽检 样本实际使用的材料却是钛二级（TA2G）。 作者： 田国宝 封图：图虫创意 登士柏西诺德（Dentsply Sirona）被指将材质为二级纯钛的人工牙种植体以四级名义对外销售，这一行为令经销商、牙科医院始料未及，并引发了他 们对未来潜在风险的担忧。 登士柏西诺德由美国登士柏和德国西诺德于2016年合并成立，业务遍及全球40多个国家。其中，登士柏成立于1899年，西诺德成立于1877年。每年有 超过60万名牙科专业人员使用登士柏西诺德的产品和解决方案，为约600万名患者提供治疗。 涉事产品为登士柏西诺德生产的XiVE S系列纯钛种植体。该系列自2017年2月起在中国注册为钛四级（TA4），但后经第三方检测，部分抽检样本实际 使用的材料却是钛二级（TA2G）。 2024年2月，登士柏西诺德将XiVE S系列产品注册材质变更为钛二级。 多位牙科医生告诉经济观察报，目前临床上使用的纯钛种植牙多为四级、五级。 登士柏西诺德的中国代理商北京盛源鸿康医疗科技有限公司（下称"盛源鸿康"）向经济观察报表示， ...

Core Viewpoint - Dentsply Sirona is accused of selling dental implants made from Grade 2 titanium under the guise of Grade 4, raising concerns among distributors and dental institutions about potential risks and fraud [2][3][12]. Group 1: Company Background - Dentsply Sirona was formed in 2016 from the merger of Dentsply and Sirona, operating in over 40 countries globally [2]. - The XiVE S series titanium implants have been registered in China since February 2017 as Grade 4 titanium (TA4) [5]. Group 2: Product Allegations - Third-party testing revealed that some samples of the XiVE S series actually used Grade 2 titanium (TA2G) instead of the claimed Grade 4 [2][3]. - In February 2024, Dentsply Sirona changed the registration of the XiVE S series from Grade 4 to Grade 2 [7]. Group 3: Market Impact - The price difference between Grade 2 and Grade 4 implants ranges from 400 to 600 yuan, with Grade 4 being the mainstream product that meets national procurement requirements [3][6]. - Dentsply Sirona's actions have led to significant financial implications, with medical institutions reportedly withholding over 50 million yuan in payments due to concerns about potential fraud [12]. Group 4: Legal and Compliance Issues - The change in product registration raises questions about compliance with national procurement standards, as only Grade 4 implants are eligible for inclusion [6][16]. - Legal risks include potential claims for medical malpractice due to the use of softer Grade 2 titanium in place of the expected Grade 4 [14][15]. Group 5: Distributor's Perspective - Beijing Shengyuan Hongkang Medical Technology Co., the distributor, has reported that they have purchased approximately 113,500 XiVE S implants since 2018, affecting over 80,000 patients [11]. - The distributor has suggested the establishment of a compensation fund by Dentsply Sirona to address potential claims but has not received a response [15].