510(k) K252731

Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant by Promimic AB — Product Code DZE

K252731 is an FDA 510(k) premarket notification submitted by Promimic AB for the device "Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant". The FDA issued a decision of Substantially Equivalent on May 12, 2026. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Promimic AB has at least 1 other 510(k) clearance on record.