510(k) K252168

Straumann® BLC Implants - Indication Widening by Institut Straumann AG — Product Code DZE

K252168 is an FDA 510(k) premarket notification submitted by Institut Straumann AG for the device "Straumann® BLC Implants - Indication Widening". The FDA issued a decision of Substantially Equivalent on March 10, 2026. 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.