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HEDSTROM FILES

DiaDent Group International · Model 31m/m 20 · UDI-DI 08806383520249

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510(k) clearances

3,925

Adverse events

Recalls

165

Facilities

Description

Files are mainly used to the preparation for various of dental pulp inflammation and dead dental pulp root canal treatment.

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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Data 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.