Recall events
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Event 94401
Event summary
Timeline bucket April 05, 2024
Product types Device
Classifications Class II
Statuses Ongoing
Recalling firm wording IVOCLAR VIVADENT AG
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
6 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 6
IPS e.max ZirCAD CER/in. Prime BL1 C17/3- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758434
Z-1703-2024
Recall number Z-1703-2024
Initiated April 05, 2024
Classification Class II
Status Ongoing
Quantity 2286 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
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-1703-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[22832]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Code information UDI-DI: (01)07615208438703 (11)231117 (10)Z063MW (241)758434 (01)07615208438703 (11)231214 (10)Z067JD(241)758434 Lot Numbers: Z063MW, Z067JD
Distribution pattern US Nationwide distribution.
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[36293]
FDA event record
· Exact recall-number query on openFDA
device · product 2 of 6
IPS e.max ZirCAD CER/in. Prime A1 C17/5 - A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758437
Z-1704-2024
Recall number Z-1704-2024
Initiated April 05, 2024
Classification Class II
Status Ongoing
Quantity 7445 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
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-1704-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[10123]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Code information UDI-DI: (01)07615208438673 (11)231214 (10)Z067J5 (241)758437; (01)07615208438673 (11)231214 (10)Z067J6 (241)758437; (01)07615208438673 (11)240112 (10)Z06CBD (241)758437; (01)07615208438673 (11)240112 (10)Z06CBF (241)758437 Batch No. Z067J5, Z067J6, Z06CBD, Z06CBF
Distribution pattern US Nationwide distribution.
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[31574]
FDA event record
· Exact recall-number query on openFDA
device · product 3 of 6
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
Z-1705-2024
Recall number Z-1705-2024
Initiated April 05, 2024
Classification Class II
Status Ongoing
Quantity 11330 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
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-1705-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16462]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Code information UDI-DI: (01)07615208438666 (11)231117 (10)Z063MX (241)758438; (01)07615208438666 (11)231214 (10)Z067JH (241)758438; (01)07615208438666 (11)240105 (10)Z06B6Y (241)758438; (01)07615208438666 (11)240118 (10)Z06D4N (241)758438 Batch No. Z063MX, Z067JH, Z067J9, Z06B6Y, Z06D4N
Distribution pattern US Nationwide distribution.
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[36301]
FDA event record
· Exact recall-number query on openFDA
device · product 4 of 6
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
Z-1706-2024
Recall number Z-1706-2024
Initiated April 05, 2024
Classification Class II
Status Ongoing
Quantity 12525 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
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-1706-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[5192]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Code information UDI-DI: (01)07615208438659 (11)231117 (10)Z063MT (241)758439; (01)07615208438659 (11)231214 (10)Z067JF (241)758439; (01)07615208438659 (11)231214 (10)Z067JC (241)758439; (01)07615208438659 (11)231214 (10)Z067JG (241)758439; (01)07615208438659 (11)231214 (10)Z067JB (241)758439; (01)07615208438659 (11)240105 (10)Z06B6Z (241)758439; (01)07615208438659 (11)240112 (10)Z06CBG (241)758439 Batch No. Z063MT, Z067JF, Z067JC, Z067JG, Z067JB, Z06B6Z, Z06CBG
Distribution pattern US Nationwide distribution.
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[31568]
FDA event record
· Exact recall-number query on openFDA
device · product 5 of 6
IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
Z-1707-2024
Recall number Z-1707-2024
Initiated April 05, 2024
Classification Class II
Status Ongoing
Quantity 4080 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
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-1707-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[46450]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Code information UDI-DI: (01)07615208438635 (11)231130 (10)Z065M0 (241)758441; (01)07615208438635 (11)240112 (10)Z06CBH (241)758441 Batch No. Z065M0, Z06CBH
Distribution pattern US Nationwide distribution.
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[31790]
FDA event record
· Exact recall-number query on openFDA
device · product 6 of 6
IPS e.max ZirCAD CER/in. Prime C2 C17/5- A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758443
Z-1708-2024
Recall number Z-1708-2024
Initiated April 05, 2024
Classification Class II
Status Ongoing
Quantity 2472 units
App-derived interpretation
Unknown
reason.no_named_rule · v1.0.0
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
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-1708-2024
Source locator 0001-device-recall-0001-of-0001.json.zip#results[16457]
Snapshot SHA-256 77e96a0ce750de9fa4bb4737d40b653784372b5abe88b9de499ad51edd808a4b
Open official device record
Compare all device evidence states
Inspect official wording and provenance
Reason for recall Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Code information UDI-DI: (01)07615208438611 (11)231130 (10)Z065M1 (241)758443 Batch No.: Z065M1
Distribution pattern US Nationwide distribution.
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[32530]
FDA event record
· Exact recall-number query on openFDA
