Institut Straumann AG

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
90
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252168Straumann® BLC Implants - Indication WideningMarch 10, 2026
K253315Straumann Variobase Abutments XC for Bridge/BarJanuary 22, 2026
K250294Straumann® RidgeFit ImplantsAugust 12, 2025
K243278Custom AbutmentsFebruary 21, 2025
K243478Straumann InLab Validated WorkflowFebruary 19, 2025
K233252Straumann CARES Visual and Nova Dental CADDecember 26, 2024
K241391Straumann® PURE Ceramic ImplantsDecember 10, 2024
K234049Straumann® BLC and TLC Implants - Line extensionMarch 20, 2024
K230108Straumann® BLC and TLC ImplantsSeptember 14, 2023
K223083Straumann SLActive labeling changesJune 22, 2023
K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsMay 15, 2023
K220878Straumann TLX Variobase CJune 16, 2022
K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAJune 2, 2022
K213063TLX SRAs and TLX Gold AbutmentsApril 8, 2022
K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsJanuary 28, 2022
K203750Straumann CARES P-Series CAD/CAM SystemOctober 9, 2021
K211052Straumann RidgeFit ImplantsJuly 8, 2021
K203456Straumann CARES M-Series CAD/CAM SystemJune 23, 2021
K210855Straumann BLX Implant SystemJune 21, 2021
K201681Straumann Immediate Temporary AbutmentsMarch 18, 2021