Doxa : receives FDA 510(k) clearance of Ceramir® Restore QuikCap

'Ceramir Restore represents a major advance towards becoming a company with a portfolio of products based on our unique Ceramir technology. The 510(k) clearance is one result of the development work that has involved the entire company, and I am proud to lead the team behind this accomplishment. It is gratifying that we have been able to focus our resources on completing this project, which has been underway for a long time. We are now awaiting the 510(k) clearance of our other novel product, Ceramir Protect,' Says Henrik Nedoh, CEO of Doxa.
Ceramir Restore is a bioactive dental filling material based on Doxa's unique Ceramir technology. The product is particularly well suited for dental care of children and seniors, as the technology's properties achieve the best results in these applications. The product falls within the category of dental filling materials for small-to-medium-sized fillings that are subject to a moderate amount of pressure. The initial feedback from users who have tested the material in simulated clinical testing has been very positive. Several of our Key Opinion Leaders are now looking forward to carrying out clinical testing of the material to be able to evaluate its uniqueness and the advantages it offers over competing materials. Just like Ceramir C&B, Ceramir Restore has the ability to remineralize the tooth tissue by means of a high pH level and calcium release, which creates dense and durable connections between the tooth tissue and the material. The market segment that Ceramir Restore now targets is estimated to be worth approximately MUSD 40 annually.
As the possibilities to conduct traditional marketing and sales work have been limited during the pandemic, Doxa made an early decision to focus the company's resources on product development during 2020. The now obtained 510(k) clearance is the result of this determined effort and constitutes a milestone for the development of Ceramir Restore as well as for Doxa as a company. The company's product portfolio thus expands to four products.
The 510(k) clearance allows the company to finalize the preparations to make the product available to U.S. distributors. The plan is for distributors to be able to offer and supply the product at the turn of the year; the precise timing may vary depending on the product introduction processes of each respective distributor.