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Advance Dental Products

The Atlanta Dental Supply Company · Model KS2580A · UDI-DI 10371347009986

EKS
10
510(k) clearances
3,963
Adverse events
3
Recalls
165
Facilities

Description

K-File SS 25mm #80 6/Pk

Recalls

DateFirmReason
2025-01-02US Endodontics, LLCDue to devices being irradiated above the established specification which my result in package integrity issues.
2012-12-12Ormco/SybronendoThe length markings on the Lightspeed LSX files were wrong.
2008-08-01Ormco CorporationA 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.