RegWardenFDA facility compliance records
Facility

IVOCLAR VIVADENT, INC.

11 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2013: 1 recalls; 2014: 1 recalls; 2015: 1 recalls; 2016: 4 recalls; 2017: 1 recalls; 2018: 1 inspections; 2020: 1 recalls; 2023: 1 recalls; 2024: 1 recalls1’131’141’154’161’171’18’191’20’21’221’231’24’25’26
  • Recalls (11)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2024-04-05
    Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
  • Class IIOngoing2023-12-21
    Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.
  • Class IITerminated2020-04-13
    Restorations crack during the sintering process.
  • Class IIITerminated2017-08-03
    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.
  • Class IITerminated2016-11-09
    The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
  • Class IITerminated2016-07-11
    After a few seconds of polishing with moderate force, parts of the OptraPol cup are breaking away. OptraPol Small Flame is also affected. Two complaints were filed referring to OptraPol, claiming that the abrasive polishers wear faster than expected.
  • Class IITerminated2016-05-27
    The primary packaging of these products may show leaks in individual cases. As a consequence, the liquid may escape inadvertently and direct contact with this liquid may lead to skin irritation.
  • Class IITerminated2016-02-12
    Complaints were received claiming the material failed to polymerize under the curing light. After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear. This failure can lead to incomplete curing of the sealant,…
  • Class IITerminated2015-07-09
    Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual.
  • Class IITerminated2014-04-14
    A stock check revealed broken glass fibers between the connector and the fiber bundle in a large number of these light probes.
  • Class IITerminated2013-09-23
    Ivoclar Vivadent, Inc. is recalling a lot of ExciTE F DSC Dental Adhesive found to produce a blue green discoloration when used in combination with cements.

FDA inspections (1)

  • VAI2018-01-11
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “IVOCLAR VIVADENT, INC. (FEI 1316092) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1316092-ivoclar-vivadent-inc/

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