Recall Z-0812-2013— Ultradent Products, Inc.

Name: FDA recall Z-0812-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-04

Class III · Terminated

Class III FDA medical device recall by Ultradent Products, Inc., initiated 2013-02-04, terminated 2013-05-30. It names one FDA 510(k) clearance: K972027. Product: Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.. Reason: Incorrect packaging of regular set and fast set cartridges..

Recalling firm: Ultradent Products, Inc.
Classification: Class III
Status: Terminated
Initiated: 2013-02-04
Terminated: 2013-05-30
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K972027 — ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)Zhermack S.P.A.·cleared 1997-07-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

Reason for recall

Incorrect packaging of regular set and fast set cartridges.

Data sourced from openFDA. This site is unofficial and independent of the FDA.