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BERLIN, Germany: On 6 January 2021, the CeramTec Group, a world innovation leader for advanced ceramics, was awarded the Certified Production Quality seal by the CleanImplant Foundation in Berlin in Germany.
“Although the approval of medical devices is largely regulated in every country, large studies still find numerous dental implants with significant particulate contamination from the production process,” explained Dr Dirk U. Duddeck, founder and CEO of the CleanImplant Foundation. “There are too few controls on dental implants. Users need more safety and better, reliable guidance to avoid putting patients at unnecessary risk,” he continued
Annual audits by accredited testing laboratories
Based on the globally established CleanImplant consensus guideline on the cleanliness of dental implants, the independent non-profit organisation is also awarding a certification confirming high production quality to contract manufacturers, producing implants for various trade brands. At least twice a year, the implants’ purity is also monitored through unannounced inspections in accredited testing laboratories, using a scanning electron microscope before the final packaging and sterilization process.
“We only deliver ceramic implants to our customers that meet the very highest quality standards and are truly clean,” emphasised Dr Hadi Saleh, CEO of the CeramTec Group. “We are pleased to be able to prove this with the current award.”
With over 3,500 employees, the CeramTec Group is the world’s leading producer of advanced ceramics for medical applications. CeramTec’s implants are metal-free and exhibit excellent biocompatibility, chemical stability, and high wear resistance.
Additional benefits for implant providers
Providers of implants produced by CeramTec do not only benefit from this award in the context of medical device regulation. The CleanImplant Foundation also facilitates access to the coveted Trusted Quality Mark for sterile-packaged end products, which is awarded after the scanning electron microscope analysis of five randomly selected samples of the same type and a final peer review of all results.