510(k) K160581

K3PRO Konus Additional Abutments and Implants by Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG — Product Code DZE

K160581 is an FDA 510(k) premarket notification submitted by Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG for the device "K3PRO Konus Additional Abutments and Implants". The FDA issued a decision of Substantially Equivalent on Mar 24, 2017. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG has 2 other 510(k) clearances on record.