Facility

Keystone Industries - Gibbstown

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

Key facts

3recalls · worst Class II

1inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010002722
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	480 S Democrat Rd Gibbstown, NJ, US 08027
Registration status	Active · expires 2026
Parent company	Keystone Industries (owner-operator 9007845)
Brand names	KeyGuide

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

Accessories, Implant, Dental, Endosseous
Product code NDP (opens in a new tab) · Class I · Dental · 21 CFR 872.3980

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 (1)

NAI2025-09-30
No 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.

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 - Gibbstown (FEI 3010002722) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010002722-keystone-industries-gibbstown/

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