Recall Z-1006-2024— Ivoclar Vivadent, Inc.

Name: FDA recall Z-1006-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-21

Class II · Ongoing

Class II FDA medical device recall by Ivoclar Vivadent, Inc., initiated 2023-12-21. It names one FDA 510(k) clearance: K820389. Product: Article No. NA6050411, Valiant PhD No. 1 Econo. Reason: Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected..

Recalling firm: Ivoclar Vivadent, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-12-21
Firm location: Amherst, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K820389 — A DENTAL AMALGAM ALLOY (UNNAMEDDentsply Intl.·cleared 1982-03-11

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

Article No. NA6050411, Valiant PhD No. 1 Econo

Reason for recall

Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.

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