FDA-Device2013-02-20Class III

Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.

Ultradent Products, Inc.
Hazard

Incorrect packaging of regular set and fast set cartridges.

Sold states
Nationwide Distribution
Affected count
32 cartridges
Manufactured in
505 W 10200 S, South Jordan, UT, United States
Products
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0811-2013

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