The FDA cleared Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue, a dental implant abutment from Institut Straumann AG (Basal, CH), under 510(k) K260460 on May 7, 2026.
FDA
The FDA cleared TriActive Dental Implant System, a endosseous dental implant from Paragon Implant Mfg., LLC (Calabasas, US), under 510(k) K261392 on September 17, 2026.
The FDA cleared X-Guide Surgical Navigation System, a dental navigation system from X-Nav Technologies, LLC (Lansdale, US), under 510(k) K253954 on August 28, 2026.
The FDA cleared Guided Bone Regeneration System, a intraosseous fixation screw from DentalMaster(Xiamen)Medical Technology Co., Ltd. (Xiamen, CN), under 510(k) K254286 on August 24, 2026.
Straumann Group reported first-half 2026 revenue of CHF 1.4 billion, 7.8% organic growth, and Q2 revenue of CHF 707.0 million. The company stated iEXCEL drove market share gains in premium implantology and Neodent expanded its geographic reach.
Straumann Group appointed Christopher Norbye as Chief Executive Officer effective December 1, 2026. He succeeds Guillaume Daniellot, who is stepping down after almost 20 years with the company, seven as CEO.
The FDA cleared ZEROS Dental Implant System, a endosseous dental implant from Zeros Co., Ltd. (Gyeongsangnam-Do, KR), under 510(k) K260463 on August 19, 2026.
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