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FibreKleer 4x
Kerr Corporation · Model N83CT · UDI-DI 10814978023339
ELR
Prescription
10
510(k) clearances
131
Adverse events
2
Recalls
98
Facilities
Description
Fiber Reinforced Post; Shape - Original; Trial Kit; 5 x 1.25 mm Posts, 1 x 1.25 mm Drill
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-21 | Coltene Whaledent Inc | ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 |
| 2009-03-20 | Dentsply Worldwide Headqrt | The product is manufactured with a left-hand thread instead of a right hand thread. This error could cause tooth breakage if the posts were removed without knowing that the thread |
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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.