The JUVORA™ dental disc has received US FDA 510(k) clearance for expanded indications, which now include the manufacture of full and partial removable dentures and implant overdentures, as well as copings, substructures (cemented or uncemented), and frameworks for permanent and transitional anterior or posterior crowns and bridgework.
Background
Claiming a major innovation in dental prosthetics for comfort, durability and precision, Juvora says it is leading the way with the next generation in dental prosthetics. Made from PEEK-OPTIMA, the dental disc is described as a modern and comfortable solution that can be used as a metal alternative for long-term implant borne, fixed and removable prosthetic frameworks. PEEK-OPTIMA high performance polymer, sourced exclusively for the dental market by Invibio Biomaterial Solutions, part of Victrex plc, an innovative world leader in high performance PEEK-based polymer solutions. JUVORA implant prosthetic frameworks can be tailor-made to patients´ specific needs, using CAD/CAM workflows, and result in reduced treatment times and better treatment outcomes.
Following its successful CE mark approval in Europe and introduction onto the European dental market in 2012, the JUVORA dental disc received initial FDA 510(k) clearance for purchase and use throughout the US in 2014. With this latest clearance, the FDA has cleared a CAD/CAM device made of PEEK polymer for the manufacture of long-term implant-borne prosthetic frameworks, compatible for use with fixed rehabilitation systems including the ALL-ON-42 treatment concept and, the STRAUMANN3 PRO ARCH system.
The PEEK-OPTIMA™ high performance polymer biomaterial has more than 15 years of proven clinical efficacy. It is sourced exclusively from Juvora´s parent company, Invibio Ltd. and offers a superior combination of strength, natural bone-like flex and toughness. More than five million PEEK-OPTIMA-based devices now implanted worldwide.
In addition to receiving endorsements from a growing number of dental labs and dental practitioners, the feedback from patients has been extremely positive. An overwhelming 99% of patients rated JUVORA prosthetics high for comfort and 97% rated them high for overall satisfaction.4
Company comments
“Patients have told us their JUVORA prosthetics feel like having their natural teeth back. This is not to mention a reduction in weight, and superior comfort through tailored fit because the prosthetic has been made with precision through CAD/CAM workflows,” noted Lynne Todd, Head of Invibio Dental and Juvora.
“Dentists in the US are now able to offer dental prosthetics that are not only more comfortable than those made from metal, but also more accurately and efficiently designed. JUVORA dental prosthetics can be a compelling alternative to metal for long term fixed as well as removable implant prosthetic applications, such as frameworks and other superstructures – both for the dentist and for their patients,” summarized Todd.
Source: Juvora
