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H-FILES
FKG Dentaire Sàrl · Model 01.153.21.035.CG · UDI-DI 07640142414902
EKS
Prescription
10
510(k) clearances
3,925
Adverse events
3
Recalls
165
Facilities
Description
H-Files 153, 21 mm, # 35, handle SMG
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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