Recall Z-0053-2021— Ultradent Products, Inc.

Name: FDA recall Z-0053-2021
Creator: U.S. Food and Drug Administration
Published: 2020-08-31

Class II · Terminated

Class II FDA medical device recall by Ultradent Products, Inc., initiated 2020-08-31, terminated 2021-10-18. It names one FDA 510(k) clearance: K974413. Product: PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.. Reason: Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous..

Recalling firm: Ultradent Products, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-08-31
Terminated: 2021-10-18
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K974413 — PERMAFLOUltradent Products, Inc.·cleared 1998-02-02

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

PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light cured, radiopaque, methacrylate based, flowable composite. PermaFlo contains H1¿m average particle size with narrow upper limit particle distribution.

Reason for recall

Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous.

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