Facility

STRATASYS LTD - Headquarter

1 recall(s) on record — most severe on record: Class III.

Key facts

1recalls · worst Class III

—inspections in our data

—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)	3017374693
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	1 Holtzman street Rehovot Central, IL 76704
Registration status	Active · expires 2026
Parent company	Stratasys Ltd (owner-operator 10086646)
Brand names	TrueDent Yellow; TrueDent Clear; TrueDent Magenta; TrueDent Cyan; TrueDent White

Activity by year

Recalls (1)

Devices registered here (4)

Additively Manufactured, Preformed, Resin Denture Tooth
Product code PZY (opens in a new tab) · Class II · Dental · 21 CFR 872.3590
Material, Tooth Shade, Resin
Product code EBF (opens in a new tab) · Class II · Dental · 21 CFR 872.3690
Crown And Bridge, Temporary, Resin
Product code EBG (opens in a new tab) · Class II · Dental · 21 CFR 872.3770
Resin, Denture, Relining, Repairing, Rebasing
Product code EBI (opens in a new tab) · Class II · Dental · 21 CFR 872.3760

Recalls & enforcement

Class IIICompleted2024-01-19
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

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. “STRATASYS LTD - Headquarter (FEI 3017374693) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3017374693-stratasys-ltd-headquarter/

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