产品质量欺诈
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全球牙科龙头登士柏被指以次充好 或涉8万余患者
Jing Ji Guan Cha Wang· 2025-08-06 13:29
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].