510(k) K241391

Straumann® PURE Ceramic Implants by Institut Straumann AG — Product Code DZE

K241391 is an FDA 510(k) premarket notification submitted by Institut Straumann AG for the device "Straumann® PURE Ceramic Implants". The FDA issued a decision of Substantially Equivalent on December 10, 2024. 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 at least 10 other 510(k) clearances on record.