Sweden gives green light to Nobel Biocare
AFP/The Local · 6 Dec 2006, 13:19
Published: 06 Dec 2006 13:19 GMT+01:00
In order to continue sales, the group will have to adjust its information policy regarding the products, the SMPA said, following an investigation into the company's product.
"The investigation showed that there can be shortcomings in the instructions for use, something that can explain the raised risk for breakdown of the jawbone that has been observed for the dental implants." the Swedish health said.
It added that Noble Biocare will have to submit a plan for clarifying the relevant details in its informational materials by January 8th or face a possible ban of the product from the Swedish market.
The investigation into NobelDirect was first prompted in May 2005, after two Swedish dentists alleged that the product caused unexpected bone loss.