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EVOFILL DUO
DiaDent Group International · Model HEATING CONDENSER (#F / #FM) · UDI-DI 08806383554909
EKR
Prescription
6
510(k) clearances
71
Adverse events
3
Recalls
143
Facilities
Description
EvoFill Duo(Gutta percha obturation System) is an electrically powered dental device used for heating Gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy.
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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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.