510(k) K230104

Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL by Anthogyr — Product Code DZE

K230104 is an FDA 510(k) premarket notification submitted by Anthogyr for the device "Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL". The FDA issued a decision of Substantially Equivalent on October 16, 2023. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Anthogyr has at least 10 other 510(k) clearances on record.