ZimVie (Nasdaq: ZIMV) announced the launch of its GenTek restorative components portfolio after receiving FDA 510(k) clearance.
This launch broadens ZimVie’s range of prosthetic offerings. According to a news release, ZimVie first introduced the GenTek portfolio in Europe in 2019 and has since reported significant success in that market.
ZimVie stated that introducing GenTek to the U.S. market brings various unique restorative components. The portfolio includes Ti-Bases, pre-milled abutment blanks, screws, instruments, and ancillary products for digitally driven CAD/CAM restorations.
The company designed and manufactured these products to perfectly fit its implant systems, ensuring a tight seal. This aims to support long-term aesthetic and functional restorations.
“We’re excited to expand our product portfolio with the introduction of GenTek premium prosthetic components, enabling digital workflows and patient-specific restorations for U.S. customers,” said Indraneel Kanaglekar, SVP, and chief commercial officer. “We have received excellent feedback and strong demand for GenTek in the European market, and we are optimistic that this product suite will be well received here in the U.S. – the largest market we serve.”
The FDA clearance comes amid reports that a South Korea-based dental implant maker may acquire ZimVie. Last month, reports indicated that the company began considering strategic alternatives, including a potential sale. At that time, ZimVie’s value was around $500 million.
This potential acquisition would occur just over two years after ZimVie spun out of orthopedic giant Zimmer Biomet. The new company combined Zimmer Biomet’s spine and dental units. However, in April, ZimVie sold its spine business, becoming a pure-play dental company.