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EdgeEndo

HSG-S Corp. · Model EOASST25HTX · UDI-DI 00810213812976

EKS Prescription

510(k) clearances

3,925

Adverse events

Recalls

165

Facilities

Description

EdgeOnyx, x-Find: Size 09.09 -15mm, x-Follow: Size 15.04 - 25mm, x-Finish: Size 20.04, 25.04, 30.04, 35.04 - 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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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.