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Hysolate

Dent4You AG · Model 60034437 · UDI-DI 07630392900263

EIE Prescription
10
510(k) clearances
31
Adverse events
1
Recalls
113
Facilities

Description

Latex DD Fiesta heavy Child (5x5), 52 pcs

Recalls

DateFirmReason
2013-12-11Coltene Whaledent IncColtne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packag

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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.