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Edge File X3
FKG Dentaire Sàrl · Model X325ASST · UDI-DI 07640452463515
EKS
Prescription
10
510(k) clearances
3,963
Adverse events
3
Recalls
165
Facilities
Description
EdgeFile X3 Assortment 17.04 17.06 20.04 20.06 25.06 30.06, 25mm
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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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.