Ultradent Products, Inc. recalls PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product U
Recalled Product
PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.
Hazard / Issue
Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.
Issued by
FDA
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