Recall events
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Event 75620
Event summary
Timeline bucket November 09, 2016
Product types Device
Classifications Class II
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
3 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 3
Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
Z-0717-2017
Recall number Z-0717-2017
Initiated November 09, 2016
Classification Class II
Status Terminated
Quantity US: 4659 units, Canada: 729 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0717-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[21284]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Code information Lot No./Expiration Date: UL2395/June 28, 2018; UL2293/Dec 31, 2017; UL2222/Aug 28, 2017; UL2220/July 28, 2017; TL4121/ Mar 28, 2017
Distribution pattern Worldwide Distribution - US Nationwide and the countries of Canada and Australia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[20222]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 3
Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material
Z-0718-2017
Recall number Z-0718-2017
Initiated November 09, 2016
Classification Class II
Status Terminated
Quantity US: 1867 units, Canada: 465 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0718-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[33972]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Code information Lot No./Expiration Date: UL2221/July 28, 2017; TL4056/Nov 28, 2016
Distribution pattern Worldwide Distribution - US Nationwide and the countries of Canada and Australia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[19983]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 3
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Z-0719-2017
Recall number Z-0719-2017
Initiated November 09, 2016
Classification Class II
Status Terminated
Quantity US: 2090 units, Canada: 331 units, Australia: 465 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
Enrichment source openFDA Device Recall
Exact join Official recall number Z-0719-2017
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10540]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Code information Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017
Distribution pattern Worldwide Distribution - US Nationwide and the countries of Canada and Australia
Official fact provenance
Dataset openFDA Device Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 1c273507f2e0fc8c5b330c3716a1392933bd90a42a460afcb7368f298d5cbd3a
Raw source locator 0001-device-enforcement-0001-of-0001.json.zip#results[18745]
FDA event record
· Exact recall-number query on openFDA
