Datum Dental's New Collagen Scaffold, OSSIX VOLUMAX, Nabs FDA Clearance
LOD, Israel and AAP, SAN DIEGO, Sept. 11 2016 /PRNewswire/ --Datum Dental announced that OSSIX® VOLUMAX has received FDA 510(k) clearance, enabling the company to commercially market this new volumizing (approx. 2 mm), resorbable collagen scaffold in the USA. It is the newest addition to the OSSIX® line of dental regeneration products for use in periodontics, oral surgery, dental Implantology and dental aesthetic procedures.
Data presented at the American Association of Periodontology (AAP) Annual Meeting Research Forum Poster Session today, clearly demonstrates statistically significant improved bone growth using OSSIX® VOLUMAX vs. empty controls.
The results also show OSSIX® VOLUMAX' mineralization and ossification progress.
Yuval Zubery, D.M.D., specialist in periodontics and Chief Medical Officer at Datum Dental, led the study and presented the findings during the poster session. Dr. Zubery will also be delivering an oral presentation at the European Association of Osseointegration (EAO) to be held later this month in Paris.
Dr. Zubery believes that OSSIX® VOLUMAX has significant potential to restore lost volume in guided bone regeneration (GBR), guided tissue regeneration (GTR) and soft tissue augmentation cases. "In implant surgery procedures where there is missing buccal bone, residual dehiscence or buccal dehiscence, this new thick collagen matrix is expected to restore volume. I foresee that clinicians may choose OSSIX® VOLUMAX for use in the esthetic zone as well, especially for masking implants."
Mr. Itay Itzhaky, Chairman at Datum Dental said: "The new OSSIX® VOLUMAX and the well-known and decade-long proven OSSIX® PLUS both feature GLYMATRIX®. This proprietary technology uses sugars to cross-link collagen molecules, producing a collagen matrix which can be bio-programmed and tailored to deliver a range of products of varying physical properties, customized longevity and controlled rates of degradation. Over 100 publications have been published to date. We will continue to develop products featuring this unique technology, for the benefit of patients and healthcare around the globe."
OSSIX® VOLUMAX is currently available in the USA (via OraPharma) & Korea (via Purgo Biologics). OSSIX VOLUMAX is pending the CE mark, Health Canada license and MOH Israel certificate. OSSIX® VOLUMAX is currently available in 4 sizes, ranging from 10 x 12.5 mm to 30 X 40 mm. For full product details, instructions for use and indications and contraindications, please visit http://www.ossixdental.com/products/ossix-volumax
About Datum Dental
Datum Dental Ltd., a subsidiary of Datum Biotech, was established in 2012 in order to develop, manufacture and market a full line of biomaterials for maxillofacial bone and soft tissue augmentation and regeneration.
Datum Dental's technology (GLYMATRIX®) is based on over 25 years of research, development, manufacturing and marketing research. Hundreds of thousands of procedures have been performed using GLYMATRIX® based products in the dental and aesthetic fields, with an excellent record of efficacy and safety. The GLYMATRIX® technology is a highly controlled and predictable technology which produces a collagen matrix with optimized bio-durability, high biocompatibility and excellent tissue regeneration properties.
Contact:
info@ossixdental.com
USA: www.ossixdental.com
Outside USA: www.ossix-dental.com
Twitter: @ossixdental
LinkedIn: www.linkedin.com/company/datum-dental
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Video - https://www.youtube.com/watch?v=ExOy4ouKkiU
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SOURCE Datum Dental LTD.
