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

Recall number

Z-0811-2013

Recalling firm

Ultradent Products, Inc.

Product

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

Status

Terminated

Initiated

2013-02-04

Posted

2013-02-13

Terminated

2013-05-30

Reason

Incorrect packaging of regular set and fast set cartridges.

Root cause

Packaging process control

Action

Ultradent Products, Inc. sent an Urgent Medical Device Correction letter dated February 4, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected products. They may continue to use product or dispose unwanted cartridges and reply back to firm indicating acknowledgement of letter and if replacement is needed. Consumers with questions can call the firm at 801-553-4420. For questions regarding this recall call 801-553-4420.

Quantity

32 cartridges

Distribution

Nationwide Distribution

Lot, serial or model codes

Part No. 5012, Lot No. B7PPC

510(k) numbers

["K972027"]

PMA numbers

not on file

Product code

ELW

Firm FEI

1718912

Firm city

South Jordan

Firm state

UT

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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