Prior to market launch, products must undergo thorough pre-clinical testing and validation. Following approval and clearance in accordance with applicable laws and regulations, Nobel Biocare solutions enter a pre-launch, or restricted use, period for clinical study.
Nobel Biocare solutions are launched to the general dental market only after satisfactory clinical results have been achieved. In the case of dental implants, this is often demonstrated by one-year cumulative survival rates (CSRs) in the mid to high ninetieth percentiles. After market introduction, product efficacy is closely monitored through observational studies as part of post-market surveillance.
Clinical studies involving implants are typically performed using demanding protocols, such as immediate loading in extraction sites, including prospective randomized controlled trials (RCTs) performed at multiple centers, using a large sampling of products and a select group of patients.
ISO certifications
Nobel Biocare’s commitment to quality is reflected in its ISO certifications for quality, environment, design, development, manufacturing, marketing, warehousing, sales, order processing and distribution. In 2007, Nobel Biocare was awarded a European Federation for Quality Management (EFQM) rating of five stars, ranking it among Europe’s leading companies.
Nobel Biocare EC Certificate No. CE 00353
Nobel Biocare Certificate No. FM 72800, CMDCAS, ISO 13485
Nobel Biocare Certificate No. MD 81731, ISO 13485
Nobel Biocare operates clinical research organizations in seven countries, as well as centers for product registration and regulatory compliance in Sweden and the USA. All Nobel Biocare products and solutions have received US Food and Drug Administration (FDA) clearance.
