The FDA cleared Neodent Scannable Healing Abutment, a dental implant abutment from JJGC Indústria e Comércio de Materiais Dentários S.A. (Curitiba, US), under 510(k) K253922 on June 15, 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.
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.
The FDA cleared Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw, a dental implant abutment from Nobel Biocare AB (Goteborg, SE), under 510(k) K253999 on August 6, 2026.
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