Institut Straumann AG - FDA 510(k) Cleared Devices
Recent clearances: Straumann® ProClean™ Cassette (041.800, Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue, Straumann® BLC Implants - Indication Widening
90
Total
90
Cleared
0
Denied
FDA 510(k) Regulatory Record - Institut Straumann AG Dental ✕
87 devices
Cleared
May 07, 2026
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue
Dental
85d
Cleared
Mar 10, 2026
Straumann® BLC Implants - Indication Widening
Dental
243d
Cleared
Jan 22, 2026
Straumann Variobase Abutments XC for Bridge/Bar
Dental
114d
Cleared
Aug 12, 2025
Straumann® RidgeFit Implants
Dental
193d
Cleared
Feb 21, 2025
Custom Abutments
Dental
128d
Cleared
Feb 19, 2025
Straumann InLab Validated Workflow
Dental
103d
Cleared
Dec 26, 2024
Straumann CARES Visual and Nova Dental CAD
Dental
455d
Cleared
Dec 10, 2024
Straumann® PURE Ceramic Implants
Dental
209d
Cleared
Mar 20, 2024
Straumann® BLC and TLC Implants - Line extension
Dental
90d
Cleared
Sep 14, 2023
Straumann® BLC and TLC Implants
Dental
244d
Cleared
Jun 22, 2023
Straumann SLActive labeling changes
Dental
265d
Cleared
May 15, 2023
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
Dental
237d
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