EJJClass II

Alloy, Amalgam

Dental · 21 CFR 872.3070

MDR events161All time

Recalls2All time

Registered firms42Currently listed

510(k) clearances74All time

Recent MDR events

161 adverse event reports on file

Event type breakdown

Injury128

Other21

Unspecified6

Malfunction5

Death1

Most-reported manufacturers

*47 Unspecified41 Unk33 Unknown9 Kerr Corporation7 Na4 Ada2 Kerr Corp.2

Recalls

2 recall events for this product code

Ivoclar Vivadent, Inc.
Open, ClassifiedFeb 7, 2024
Article No. NA6050411, Valiant PhD No. 1 Econo
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.
Z-1006-2024 · View FDA record ↗
Kerr Corporation
TerminatedJun 13, 2014
Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294.
Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use.
Z-1788-2014 · View FDA record ↗

Registered firms

42 firms currently registered for this product code

510(k) clearances

74 clearances for this product code