Exact FDA event identifier

Event 64272

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: February 04, 2013
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Ultradent Products, Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 2

Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.

Z-0811-2013

Recall number: Z-0811-2013
Initiated: February 04, 2013
Classification: Class III
Status: Terminated
Recalling firm: Ultradent Products, Inc.
Quantity: 32 cartridges

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Incorrect packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Incorrect packaging of regular set and fast set cartridges.

Code information

Part No. 5012, Lot No. B7PPC

Distribution pattern

Nationwide Distribution

device · product 2 of 2

Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.

Z-0812-2013

Recall number: Z-0812-2013
Initiated: February 04, 2013
Classification: Class III
Status: Terminated
Recalling firm: Ultradent Products, Inc.
Quantity: 100 cartridges