510(k) K251046

S.I.N. Dental Implant System by S.I.N. Implant System Ltda — Product Code DZE

K251046 is an FDA 510(k) premarket notification submitted by S.I.N. Implant System Ltda for the device "S.I.N. Dental Implant System". The FDA issued a decision of Substantially Equivalent on August 13, 2025. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. S.I.N. Implant System Ltda has at least 3 other 510(k) clearances on record.