Exact FDA event identifier

Event 79064

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

Event summary

Timeline bucket: August 03, 2017
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Ivoclar Vivadent, 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

4 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 4

Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501

Z-0665-2018

Recall number: Z-0665-2018
Initiated: August 03, 2017
Classification: Class III
Status: Terminated
Recalling firm: Ivoclar Vivadent, Inc.
Quantity: 2,153 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

Code information

Batch: V35109 Exp. date: 01.10.2020; Batch: V40817 Exp. date: 13.11.2020; Batch: V48597 Exp. date: 30.12.2020; Batch: V48938 Exp. date: 31.12.2020 Batch: W12251 Exp. date: 31.03.2021

Distribution pattern

US and Canada

device · product 2 of 4

Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502

Z-0666-2018

Recall number: Z-0666-2018
Initiated: August 03, 2017
Classification: Class III
Status: Terminated
Recalling firm: Ivoclar Vivadent, Inc.
Quantity: 3,255 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

Code information

Batch: V37176, Exp. date: 15.10.2020; Batch: V40818, Exp. date: 13.11.2020; Batch: V45145, Exp. date: 05.12.2020; Batch: V51367, Exp. date: 22.01.2021; Batch: W00520, Exp. date: 29.01.2021; Batch: W01514, Exp. date: 04.02.2021; Batch: W07036, Exp. date: 05.03.2021; Batch: W13323, Exp. date: 07.04.2021

Distribution pattern

US and Canada

device · product 3 of 4

Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503

Z-0667-2018

Recall number: Z-0667-2018
Initiated: August 03, 2017
Classification: Class III
Status: Terminated
Recalling firm: Ivoclar Vivadent, Inc.
Quantity: 1,244 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

Code information

Batch: V37905, Exp. date: 21.10.2020; Batch: V45006, Exp. date: 04.12.2020; Batch: V49583, Exp. date: 12.01.2021; Batch: W04412, Exp. date: 20.02.2021; Batch: W13322, Exp. date: 07.04.2021

Distribution pattern

US and Canada

device · product 4 of 4

Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559

Z-0668-2018

Recall number: Z-0668-2018
Initiated: August 03, 2017
Classification: Class III
Status: Terminated
Recalling firm: Ivoclar Vivadent, Inc.
Quantity: 2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.

Code information

Batch: W12503, Exp. date: 01.04.2021

Distribution pattern

US and Canada