ISRIE
Hansfive (Hangzhou) Dental Technology Co.,Ltd. · Model G3-G1708-19,G3-G1902-25,G3-G1506-25,G3-G2504-25,G3-G2506-25, G3-G3504-25 · UDI-DI 06975043365987
10
510(k) clearances
3,925
Adverse events
3
Recalls
165
Facilities
Description
Nickel Titanium Root Canal File 6 psc/pack Including G3-G1708-19,G3-G1902-25,G3-G1506-25,G3-G2504-25,G3-G2506-25, G3-G3504-25.
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.