The FDA cleared Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut), a dental implant abutment from Smart Denture Conversions, LLC (Apex, US), under 510(k) K254145 on June 11, 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.
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.
Sen. Alsobrooks, with Sens. Blumenthal and Merkley, introduced S. 5089 to add dental services to Medicare, including major services such as crowns and dentures, with payment rules for dental prostheses. Coverage would apply to services on or after January 1, 2028.
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