RegWardenFDA facility compliance records
Company

PRISMATIK DENTALCRAFT, INC.

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

Recalls by year

FDA actions on record by year2016: 1 recalls; 2025: 2 recalls; 2026: 1 recalls12016201720182019202020212022202320242202512026
  • Recalls (4)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2026-04-27
    Due to device not having FDA Clearance
  • Class IIOngoing2025-09-30
    Incorrect titanium screw, packaged with dental implant.
  • Class IIOngoing2025-04-14
    Due to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside.
  • Class IITerminated2016-08-15
    Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “PRISMATIK DENTALCRAFT, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10043585-prismatik-dentalcraft-inc/

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