EKNClass I

Point, Paper, Endodontic

Dental · 21 CFR 872.3830

MDR events0All time

Recalls5All time

Registered firms86Currently listed

510(k) clearances7All time

Recent MDR events

0 adverse event reports on file

No MDR events on file for this product code.

Event type breakdown

No data available.

Most-reported manufacturers

No data available.

Recalls

5 recall events for this product code

Ultradent Products, Inc.
TerminatedUnknown
Ultradent Products, Inc. Paper Points, Size 20 PN #1560, 200 per container, sterile.
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Z-3214-2017 · View FDA record ↗
Ultradent Products, Inc.
TerminatedUnknown
Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile.
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Z-3215-2017 · View FDA record ↗
Ultradent Products, Inc.
TerminatedUnknown
Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile.
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Z-3216-2017 · View FDA record ↗
Ultradent Products, Inc.
TerminatedUnknown
Ultradent Products, Inc. Paper Points, Size 45 PN #1558, 200 per container, sterile.
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Z-3217-2017 · View FDA record ↗
Ultradent Products, Inc.
TerminatedUnknown
Ultradent Products, Inc. Paper Points, Size 50 PN #1559, 200 per container, sterile.
The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
Z-3218-2017 · View FDA record ↗

Registered firms

86 firms currently registered for this product code

510(k) clearances

7 clearances for this product code