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BIODENTINE

SEPTODONT SAS SPECIALITES SEPTODONT · Model 01C0600 · UDI-DI 03760140703335

EJK KIF Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Bioactive dentin substitute

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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Data 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.