EKHClass I

Carver, Dental Amalgam, Operative

Dental · 21 CFR 872.4565

MDR events17All time

Recalls1All time

Registered firms95Currently listed

510(k) clearances3All time

Recent MDR events

17 adverse event reports on file

Event type breakdown

Injury16

Death1

Most-reported manufacturers

Unknown8 Unk6 Unspecified2 Na1

Recalls

1 recall events for this product code

Almore International Inc
TerminatedMay 10, 2017
Microfil Composite Instruments are packaged in an unsealed plastic sleeve, which is then placed in a cardboard box. Microfil Composite Instruments are intended
Microfil Composite Instruments were distributed with a sterile symbol on their packaging label inserts, indicating that the products are sold as sterile devices. These products are not sterile and they are intended to be sterile prior to each use.
Z-2069-2017 · View FDA record ↗

Registered firms

95 firms currently registered for this product code

510(k) clearances

3 clearances for this product code