510(k) K210134

Dentis s-Clean s-Line by Dentis Co., Ltd. — Product Code DZE

K210134 is an FDA 510(k) premarket notification submitted by Dentis Co., Ltd. for the device "Dentis s-Clean s-Line". The FDA issued a decision of Substantially Equivalent on April 19, 2021. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Dentis Co., Ltd. has at least 10 other 510(k) clearances on record.