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FlowLogic Variety Kit
SONENDO, INC. · Model FG-016-00011-02 · UDI-DI 00810209421373
EKS
Prescription
10
510(k) clearances
3,984
Adverse events
3
Recalls
170
Facilities
Description
FlowLogic Variety Kit, 25mm 00810209420901 (Qty:1) 00810209420932 (Qty:1) 00810209421151 (Qty:1) 00810209420956 (Qty:1) 00810209421359 (Qty:1) 00810209420918 (Qty:1)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-02 | US Endodontics, LLC | Due to devices being irradiated above the established specification which my result in package integrity issues. |
| 2012-12-12 | Ormco/Sybronendo | The length markings on the Lightspeed LSX files were wrong. |
| 2008-08-01 | Ormco Corporation | A recall was initiated because SybronEndo has confirmed that the K3 Engine File G-Pack has label packaging and file mis-marking error. |
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