# China NMPA Product Recall - Dental Ingots (IPS e.max)

Source: https://www.globalkeysolutions.net/records/china_product_recall/ivoclar-vivadent-ag/9537209d-713b-4dfd-a724-ec43187c97a1/
Source feed: China

> China NMPA product recall for Dental Ingots (IPS e.max) by Ivoclar Vivadent AG published April 22, 2020. Recall level: Level 3. Ivoclar Vivadent (Shanghai) Trading Co., Ltd. reported a voluntary Class III recall initiated by its

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Ivoire Vardent (Shanghai) Trading Co., Ltd. has initiated a voluntary recall of its all-ceramic dental blocks (IPS e.max Dental Ingots).
- Company Name: Ivoclar Vivadent AG
- Publication Date: 2020-04-22
- Product Name: Dental Ingots (IPS e.max)
- Recall Level: Level 3
- Recall Reason: The issue involves the possibility of cracks appearing in the repair materials made from the product after sintering.
- Discovering Company: Ivoire Vardent (Shanghai) Trading Co., Ltd.
- Manufacturing Company: Ivoclar Vivadent AG
- Summary: Ivoclar Vivadent (Shanghai) Trading Co., Ltd. reported a voluntary Class III recall initiated by its manufacturer, Ivoclar Vivadent AG, concerning specific batches of dental all-ceramic blocks, marketed as IPS e.max Dental Ingots (Registration Certificate No.: 20142176059). The National Medical Products Administration (NMPA) published this information on April 22, 2020, following the report from the Shanghai Municipal Drug Administration. The primary issue prompting this recall is the potential for cracking in restorative materials fabricated from these dental blocks post-sintering. This defect could compromise the integrity and performance of dental restorations, posing a risk to patient safety and product efficacy. Under the oversight of the NMPA, Ivoclar Vivadent AG has taken the required action of a voluntary recall to address this product defect. A Class III recall typically signifies a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. Specific details regarding the affected product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This proactive measure aims to mitigate potential risks associated with the faulty dental materials and ensure compliance with medical device quality standards.

Company: https://www.globalkeysolutions.net/companies/ivoclar-vivadent-ag/6e8092a2-9da0-49b1-a7f4-d83caedf40e1/