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OSUNG MND
OSUNG MND Co., Ltd. · Model RCP10 · UDI-DI 08800075612205
6
510(k) clearances
71
Adverse events
3
Recalls
143
Facilities
Description
A hand-held, manually-operated, dental instrument specifically designed to compress filling materials in a root canal, mainly in an axial direction. The working distal end is cylindrical or tapered, circular in cross-section, and has a flat-tipped end. This is a reusable device.
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.