RegWardenFDA facility compliance records
Facility

Keystone Industries

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

Activity by year

FDA actions on record by year2022: 1 inspections; 2023: 3 recalls; 2025: 1 inspections2017201820192020202112022320232024120252026
  • Recalls (3)
  • Inspections (2)

Devices registered here (1)

  • Resin, Denture, Relining, Repairing, Rebasing
    Product code EBI (opens in a new tab) · Class II · Dental · 21 CFR 872.3760

Recalls & enforcement

  • Class IIOngoing2023-11-20
    Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).
  • Class IIOngoing2023-07-21
    A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526).
  • Class IIOngoing2023-04-10
    The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials

FDA inspections (2)

  • NAI2025-07-25
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2022-11-17
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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. “Keystone Industries (FEI 1000121639) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000121639-keystone-industries/

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