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Insti-Dam®

ZIRC DENTAL PRODUCTS, INC. · Model 50Z459-360 · UDI-DI 10840161302707

EIE Prescription
10
510(k) clearances
31
Adverse events
1
Recalls
114
Facilities

Description

Original InstiDam 5pk for Isolation Power Pack

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.