510(k) K253999

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 by Nobel Biocare AB — Product Code NHA

K253999 is an FDA 510(k) premarket notification submitted by Nobel Biocare AB for the device "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". The FDA issued a decision of Substantially Equivalent on August 6, 2026. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Nobel Biocare AB has at least 10 other 510(k) clearances on record.