Data / Medical devices / Israel / STRATASYS LTD - Headquarter

STRATASYS LTD - Headquarter: FDA-registered device maker in Rehovot Central, Israel, 1 510(k) clearance

Name: STRATASYS LTD - Headquarter FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

STRATASYS LTD - Headquarter is registered with the FDA (registration 3017374693) in Rehovot Central, Israel. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 7, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017374693
Address: 1 Holtzman street, Rehovot Central, Israel, 7670401
Owner or operator: Stratasys Ltd (10086646)
Roles: Complaint file establishment, Specification developer
First device listed: November 29, 2022
Registered through: 2026
Brand names listed: MED610, MED610-DSG, TrueDent Clear, TrueDent Cyan, TrueDent Magenta, TrueDent White, TrueDent Yellow

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture Tooth	PZY	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Material, Tooth Shade, Resin	EBF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Complaint file establishment, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 7, 2022	K220771	Stratasys TrueDent	EBI	Substantially Equivalent	Stratasys, Ltd.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 19, 2024	97021	Class III	Completed	TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances	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.	accessdata.fda.gov

Compare with other makers

Updated July 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.