OSSIX Bone Cleared for Use in Canada and Europe

Richard Gawel

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Datum Dental’s OSSIX Bone has qualified for the CE Mark in Europe and has been approved by Health Canada. Powered by the company’s GLYMATRIX core technology, OSSIX Bone was cleared by the Food and Drug Administration in July 2017 and launched commercially in the United States last year.

“OSSIX Bone is a mineralized collagen sponge with unique ossifying characteristics and texture that enable simplified dental procedures in challenging cases as well as routine care,” said Dr. Arie Goldlust, Datum Dental CEO and cofounder. “Unlike alternatives on the market including allograft/xenograft materials, OSSIX Bone promotes true bone with no remnants, no migration of material, offering a viable, naturally derived solution for clinicians.”

“Based on my clinical experience, this biomaterial has changed the way I approach crestal sinus elevations and grafting extraction sites. The easy handling of OSSIX Bone translates into precise and safe augmentation, with predictable ossification and osseointegration without the risks of graft migration,” said Barry Levin, DMD.

“This gives patients and clinicians a better option: providing a simplified and predictable way to preserve alveolar ridge dimensions for ideal implant placement, with no need for a membrane. Having a material like the OSSIX Bone collagen sponge that readily absorbs the patient’s blood, ie, growth factors, and remains stable after placement is a tremendous improvement over available grafting materials,” said Levin. 

“We are bringing these unique and innovative materials to Canada so that patients may achieve optimal treatment outcomes. We are pleased to offer a simpler solution to socket preservations and crestal/closed sinus lift techniques with the newly Health Canada licensed OSSIX Bone,” said Chris Carriere, managing director of Hesira Med.

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