FDA-Device2022-05-25Class II
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
Clinician's Choice Dental Products Inc.
Hazard
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
Sold states
Distributed in SC.
Affected count
46 units
Manufactured in
559 Federal Rd Unit B, N/A, Brookfield, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1100-2022Don't want to check this manually?
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