The FDA cleared MegaGen Zygoma Dental Implant System, a endosseous dental implant from Megagen Implant Co., Ltd. (Deagu, KR), under 510(k) K251232 on June 18, 2026.
FDA
MegaGen introduced the BLUEDIAMOND ZYGOMA implant system to the U.S. market at its North America Scientific Meeting in Chicago, September 18 to 19, 2026, after FDA clearance in June 2026. The system is for patients with severe maxillary atrophy and supports immediate and delayed loading.
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.
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