The FDA cleared BioHorizons CEREC Compatible Ti-Bases, a dental implant abutment from BioHorizons Implant Systems, Inc. (Birmingham, US), under 510(k) K260061 on June 26, 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.
Xtant Medical named BioHorizons, a Henry Schein subsidiary, exclusive distributor of its OsteoFactor Pro allogeneic growth factor in the U.S. and Canadian dental and oral-maxillofacial markets. BioHorizons sells the product as Prolifica.
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.
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