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iLumi
Ilumi Sciences, Inc. · Model SK-9123 · UDI-DI 00850692005698
10
510(k) clearances
131
Adverse events
2
Recalls
97
Facilities
Description
15 Super Fiber Posts (serrated), 5 each 1.35, 1.47, 1.67 mm & 3 matching drills.
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.