510(k) K211921

S.I.N. Dental Implant System by S.I.N. - Sistema DE Implante Nacional S.A. — Product Code DZE

K211921 is an FDA 510(k) premarket notification submitted by S.I.N. - Sistema DE Implante Nacional S.A. for the device "S.I.N. Dental Implant System". The FDA issued a decision of Substantially Equivalent on October 20, 2021. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. S.I.N. - Sistema DE Implante Nacional S.A. has at least 10 other 510(k) clearances on record.