510(k) K212533

BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants by Institut Straumann AG — Product Code DZE

K212533 is an FDA 510(k) premarket notification submitted by Institut Straumann AG for the device "BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants". The FDA issued a decision of Substantially Equivalent on January 28, 2022. 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.