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Endo@pex

DXM CO., LTD · Model Endo@pex · UDI-DI 08800017900001

EKR Prescription

510(k) clearances

Adverse events

Recalls

143

Facilities

Description

The Lightest and Most Efficient 2-in-1 Cordless Obturation System Endo-Apex is one of the most advanced and efficient cordless obturation system ever introduced. Endo-Apex successfully delivers predictable results in vertical condensation and 3 dimensional thermo-plasticized obturation. The 2 most effective individual obturation device (Friendo, Gutta Easy) are beautifully combined as one convenient package for maximum efficiency

Recalls

Date	Firm	Reason
2017-12-27	Ormco/Sybronendo	Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU).
2013-01-17	Ormco/Sybronendo	A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Uni
2013-01-17	Ormco/Sybronendo	A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed cautionary statement label was inadvertently omitted from the Elements Obturation Uni

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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.