Rodo Medical, a dental device company, has secured FDA clearance of the Rodo abutment system, featuring the shape-memory Smileloc retentive sleeve.
The Rodo abutment aystem radically simplifies the process for placing and retrieving restorations by eliminating the need for cement or screws for retaining the prosthesis.
The Smileloc, combined with the proprietary Rodo abutment and coping, uses the shape memory material Nitinol to create an entirely new attachment between a restoration and a dental implant. This technology eliminates the need for cement or screws and allows the prosthesis to be removed using the Smileloc "Key."
Data supporting the FDA's clearance of the Rodo Abutment System included extensive bench testing, as well as a prospective multi-center clinical trial involving single-tooth restorations and full-arch prostheses. The clinical evidence and FDA submission were managed by PaxMed International, LLC of San Diego, CA.
The Rodo Abutment System received FDA clearance to be used in conjunction with compatible implant systems in the upper and lower jaw to retain crowns, bridges and overdentures.
Smileloc is currently compatible with NobelBiocare, Straumann, and Neodent implant systems. Rodo Medical will expand the product line by adding compatibility with other dental implant systems, based upon interest and demand.
"Rodo Medical has been working on this technology for many years and we are very pleased to be able to offer this revolutionary technology to dental professionals in the US and abroad. We believe the Smileloc is simple to use and dramatically improves patient care and will eliminate many of the complications currently experienced in implant dentistry," said Young Seo, CEO and President of Rodo Medical.
"This innovative, cement-free solution will set a new standard of care for implant dentistry," said Dr. Benjamin Wu, Professor and Chairman of UCLA Division of Advanced Prosthodontics and Chairman of Rodo Medical Scientific Advisory Board.
The Rodo abutment system and Smileloc will be available in early 2017 at select dental offices in conjunction with certified dental labs in the US.