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INTERFACE

TEMREX CORPORATION · Model 7110 · UDI-DI 00850015110443

EJK
1
510(k) clearances
14
Adverse events
1
Recalls
50
Facilities

Description

DENTAL CAVITY LINER DENTIN SHADE

Recalls

DateFirmReason
2014-06-05Axcentria Pharmaceuticals, LLCOne 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.