China NMPA Product Recall - Light-cured fissure sealant with fluoride release

On October 22, 2020, Ivoire Vivadent (Shanghai) Trading Co., Ltd. initiated a voluntary, Level III recall for its Light-cured fissure sealant with fluoride release. This action was publicly reported by the Shanghai Municipal Drug Administration, operating under the regulatory framework of the National Medical Products Administration (NMPA) in China. The primary reason for this recall stemmed from identified discrepancies between the information displayed on the product's Chinese label and the official details recorded in its registration certificate (No.: 20172636292). A Level III recall indicates that while the labeling issue is significant enough to warrant corrective action for regulatory compliance and accurate consumer information, the product is unlikely to cause serious adverse health consequences. No specific inspection dates were provided in the document, with the recall being announced on the aforementioned date. As a required action, Ivoire Vivadent is responsible for removing all affected batches and specifications of the medical device from the market. Comprehensive details regarding the specific models and batch numbers involved are documented in an accompanying 'Medical Device Recall Event Report Form'.