Clinician's Choice Dental Products Inc. recalls Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, vi…

Recall date

March 18, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1100-2022

FDA classification

Class II

Brand / firm

Clinician's Choice Dental Products Inc.

Sold / distributed

Distributed in SC.

Why it was recalled

Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912