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APOZA
APOZA ENTERPRISE CO., LTD. · Model GP Easy II · UDI-DI 04719883751300
6
510(k) clearances
71
Adverse events
3
Recalls
143
Facilities
Description
GP obturation device is applied to professional dentistry, which cuts off and softens root canal filling material for making it more easily filled into all places inside root canal during root canal treatment.
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.