Recall Z-0876-2013— Ultradent Products, Inc.

Name: FDA recall Z-0876-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-08

Class III · Terminated

Class III FDA medical device recall by Ultradent Products, Inc., initiated 2013-02-08, terminated 2013-06-07. It names one FDA 510(k) clearance: K922499. Product: Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.. Reason: Orthodontic brackets distributed was incorrectly labeled..

Recalling firm: Ultradent Products, Inc.
Classification: Class III
Status: Terminated
Initiated: 2013-02-08
Terminated: 2013-06-07
Firm location: South Jordan, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K922499 — REFLECTIONS - CERAMIC DENTAL BRACKETCdb Corp.·cleared 1992-07-30

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

Avex CX Suite, Avex CX 0.22 UL4,5 HK REF #224-017, Product Usage: Avex CX ceramic brackets are formed with 99.9% pure alumina oxide. The indicated use of the Avex CX ceramic bracket is the mechanical movement of natural teeth in conjunction with other components designed to attach to the brackets.

Reason for recall

Orthodontic brackets distributed was incorrectly labeled.

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