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BENCO
BENCO DENTAL SUPPLY CO. · Model 5095-498 · UDI-DI 00366975005151
10
510(k) clearances
412
Adverse events
4
Recalls
243
Facilities
Description
Burnisher DE #1 Ball
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-11-14 | The Anspach Effort, Inc. | May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start. |
| 2014-11-06 | Synthes (USA) Products LLC | The device may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. Unintended start of the hand piece or wrong mode/ |
| 2014-08-14 | The Anspach Effort, Inc. | The affected Small Electric Drive (SED) may operate solely in reverse mode, not operate in reverse mode when intended, not function, or unintentionally start. |
| 2009-09-03 | Synthes USA (HQ), Inc. | The recalling firm has determined that the customized plates instruments do not have a cleared premarket notification. |
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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.