Nobel Biocare, a leading supplier of restorative and esthetic dental solutions, has introduced dental healing caps made of Eviva polysulfone (PSU) resin from Solvay Advanced Polymers, LLC, for excellent biocompatibility, practical toughness, and sterilizability via gamma radiation. Eviva PSU resin is part of Solvay’s Solviva line of biomaterials that are offered for use in implantable medical devices.
In dental implant applications such as tooth replacements, the dental healing caps must be biocompatible with the gum tissue, according to Steve Hurson, Nobel Biocare chief scientist. Typically, the implant (titanium screw) is screwed into the bone, an abutment is placed into the implant, and a healing cap snaps onto the abutment. When the tissue heals, the cap is removed and a replacement tooth is cemented on.
These thimble-like injection molded caps are normally 4 mm to 6 mm in diameter and 4 mm high. Marman Industries Inc., an injection molder based in LaVerne, Calif., manufactures the caps. Eviva PSU resin is available in either opaque white or transparent natural. Based on biocompatibility testing, it demonstrates no evidence of cytotoxicity, sensitization, irritation, or acute systemic toxicity.
Eviva PSU and the entire line of Solviva Biomaterials are manufactured in compliance with the relevant aspects of ISO 13485 and under the relevant aspects of current Good Manufacturing Practices. Solvay’s biomaterial manufacturing processes are carefully validated and enhanced controls provide product traceability. In addition, all materials are tested in an accredited lab that is ISO 17025 compliant.
Nobel Biocare plans to offer the Eviva PSU healing caps to dentists and surgeons worldwide.
In addition to Eviva PSU, Solvay’s Solviva biomaterials line includes Zeniva PEEK, which boasts a modulus very close to that of bone plus excellent biocompatibility, toughness, and fatigue resistance; Proniva self-reinforced polyphenylene (SRP), one of the world’s stiffest and strongest unreinforced thermoplastic that offers exceptional hardness and biocompatibility; and Veriva polyphenylsulfone (PPSU), which provides unsurpassed toughness combined with transparency and excellent biocompatibility. These sterilizable products are available in injection and extrusion grades as well as stock shapes for machined components.
Solvay’s experience as a key materials supplier in the healthcare field spans more than 20 years. The company is a leading manufacturer of high-performance plastics, offering a broad range of materials for healthcare instruments and medical devices. More recently, Solvay has successfully introduced its line of Solviva Biomaterials and offers them for use in a range of implantable devices.