Institut Straumann AG
FDA 510(k) & PMA Approved Devices — 57 products
Total Devices57
Categories9
Latest FDA decision2026-06-03
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K260726 | Straumann® ProClean™ Cassette (041.800 ; 041.801) | KCT | 2026-06-03 | View |
| 510(k) | K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | NHA | 2026-05-07 | View |
| 510(k) | K252168 | Straumann® BLC Implants - Indication Widening | DZE | 2026-03-10 | View |
| 510(k) | K253315 | Straumann Variobase Abutments XC for Bridge/Bar | NHA | 2026-01-22 | View |
| 510(k) | K250294 | Straumann® RidgeFit Implants | DZE | 2025-08-12 | View |
| 510(k) | K243278 | Custom Abutments | NHA | 2025-02-21 | View |
| 510(k) | K243478 | Straumann InLab Validated Workflow | NHA | 2025-02-19 | View |
| 510(k) | K233252 | Straumann CARES Visual and Nova Dental CAD | PNP | 2024-12-26 | View |
| 510(k) | K241391 | Straumann® PURE Ceramic Implants | DZE | 2024-12-10 | View |
| 510(k) | K234049 | Straumann® BLC and TLC Implants - Line extension | DZE | 2024-03-20 | View |
| 510(k) | K230108 | Straumann® BLC and TLC Implants | DZE | 2023-09-14 | View |
| 510(k) | K223083 | Straumann SLActive labeling changes | DZE | 2023-06-22 | View |
| 510(k) | K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | NHA | 2023-05-15 | View |
| 510(k) | K220878 | Straumann TLX Variobase C | NHA | 2022-06-16 | View |
| 510(k) | K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | NHA | 2022-06-02 | View |
| 510(k) | K213063 | TLX SRAs and TLX Gold Abutments | NHA | 2022-04-08 | View |
| 510(k) | K212533 | BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants | DZE | 2022-01-28 | View |
| 510(k) | K203750 | Straumann CARES P-Series CAD/CAM System | NHA | 2021-10-09 | View |
| 510(k) | K211052 | Straumann RidgeFit Implants | DZE | 2021-07-08 | View |
| 510(k) | K203456 | Straumann CARES M-Series CAD/CAM System | NHA | 2021-06-23 | View |
No matching devices.
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