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ROOT-CAL
Cynosure, LLC · Model ERC137 · UDI-DI 00841494104504
EJK
Prescription
10
510(k) clearances
14
Adverse events
1
Recalls
50
Facilities
Description
ROOT-CAL,2.5ML SYRINGE 98% CAL HYDROXIDE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2014-06-05 | Axcentria Pharmaceuticals, LLC | One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for |
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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.