510(k) K181703

Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments by Institut Straumann AG — Product Code DZE

K181703 is an FDA 510(k) premarket notification submitted by Institut Straumann AG for the device "Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments". The FDA issued a decision of Substantially Equivalent on Dec 28, 2018. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Institut Straumann AG has 91 other 510(k) clearances on record.