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KLOCKNER
SOADCO, S.L. · Model 82 11 02 02 · UDI-DI 08435451628947
4
510(k) clearances
4,902
Adverse events
57
Recalls
530
Facilities
Description
i-ST 6 SCAN ABUTMENT
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-01-06 | Straumann USA LLC | The mix up of the impression caps provided in the package. The provided impression caps are magenta instead of brown. |
| 2025-07-24 | Dentsply IH, Inc. | The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage appr |
| 2025-07-24 | Dentsply IH, Inc. | The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage appr |
| 2025-04-14 | Prismatik Dentalcraft, Inc. | Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside. |
| 2025-03-08 | Straumann USA LLC | The devices are missing the laser marked depth markings. |
| 2024-06-25 | Preat Corp | Due to a manufacturing issue, the product has a out of specification rotation of the digital analog used to visually inspect dental abutments and restorations. |
| 2024-01-24 | Thommen Medical AG | The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant. |
| 2023-12-27 | TruAbutment Inc. | Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately |
| 2021-07-26 | Paltop Advanced Dental Solutions Ltd | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size eng |
| 2021-07-26 | Paltop Advanced Dental Solutions Ltd | Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size eng |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.