510(k) K171784

Straumann Dental Implant System by Straumann USA, LLC — Product Code DZE

K171784 is an FDA 510(k) premarket notification submitted by Straumann USA, LLC for the device "Straumann Dental Implant System". The FDA issued a decision of Substantially Equivalent on January 19, 2018. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Straumann USA, LLC has at least 10 other 510(k) clearances on record.