510(k) K251205

Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants by Dentsply Sirona — Product Code NHA

K251205 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants". The FDA issued a decision of Substantially Equivalent on November 21, 2025. The device falls under product code NHA (Abutment, Implant, Dental, Endosseous), a Class II device regulated under 21 CFR 872.3630. Dentsply Sirona has at least 10 other 510(k) clearances on record.