China NMPA Product Recall - Nobel Procera Dental Ceramics

Nobel Biocare AB, in collaboration with Nobel Biocare Trading (Shanghai) Co., Ltd., has initiated a voluntary Class II recall for specific models and batches of its Nobel Procera Dental Ceramics. This action, reported to the National Medical Products Administration (NMPA) on June 30, 2021, originates from a manufacturing issue identified in March 2021. The primary concern is a sintering furnace malfunction during production, which prevented certain products from achieving the required sintering curve. This deviation could potentially compromise the quality and performance of the affected dental ceramics. The recall targets products covered by Registration Certificate No.: 20162635088, with detailed information on specific models and batches available in the "Medical Device Report Form." This proactive measure reflects Nobel Biocare AB's commitment to product safety and adherence to NMPA regulatory standards, ensuring the removal of non-conforming products from the market to protect patient health.