510(k) K162890

BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment by Straumann USA, LLC — Product Code DZE

K162890 is an FDA 510(k) premarket notification submitted by Straumann USA, LLC for the device "BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment". The FDA issued a decision of Substantially Equivalent on March 8, 2017. 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.