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BENCO SPHERICAL

SDI LIMITED · Model 5102363 · UDI-DI 29336472004754

EJJ
1
510(k) clearances
161
Adverse events (1 deaths)
2
Recalls
19
Facilities

Description

BENCO SPHR 2SP REG 50

Recalls

DateFirmReason
2023-12-21Ivoclar Vivadent, Inc.Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be ad
2014-05-29Kerr CorporationKerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use.

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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.