IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748 3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306 4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450, 5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465 Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base
FDA Recall Z-2089-2016 · Posted 2016-06-29
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Reason for Recall
Firm Action
Root Cause
Material/Component Contamination
Distribution Pattern
Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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