510(k) K220841

PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) by Dentsply Sirona — Product Code DZE

K220841 is an FDA 510(k) premarket notification submitted by Dentsply Sirona for the device "PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)". The FDA issued a decision of Substantially Equivalent on Nov 16, 2022. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Dentsply Sirona has 87 other 510(k) clearances on record.