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STRATASYS LTD

Israel·IL-MF-000040298

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Med610	MED610 1.1Kg	FDA UDI	Class I	Active
Med610	MED610 4kg (J5 DentaJet)	FDA UDI	Class I	Active
Med610	MED610 4Kg	FDA UDI	Class I	Active
Med610	MED610 1Kg	FDA UDI	Class I	Active
Med610	MED610 3.6Kg	FDA UDI	Class I	Active
TrueDent-D Magenta	OBJ-09303	EUDAMED	Class I	Active
TrueDent Magenta	OBJ-09166	EUDAMEDFDA UDI	Class IIa	Active
TrueDent White	OBJ-09168	EUDAMEDFDA UDI	Class IIa	Active
TrueDent-D Yellow	OBJ-09305	EUDAMED	Class I	Active
TrueDent-D White	OBJ-09304	EUDAMED	Class I	Active
TrueDent Yellow	OBJ-09169	EUDAMEDFDA UDI	Class IIa	Active
TrueDent-D Cyan	OBJ-09302	EUDAMED	Class I	Active
TrueDent Clear	OBJ-09164	EUDAMEDFDA UDI	Class IIa	Active
MED610-DSG™ Biocompatible Clear	OBJ-03385	EUDAMEDFDA UDI	Class I	Active
MED610-DSG™ Biocompatible Clear	OBJ-09193	EUDAMEDFDA UDI	Class I	Active
TrueDent-D Clear	OBJ-09301	EUDAMED	Class I	Active
TrueDent Cyan	OBJ-09165	EUDAMEDFDA UDI	Class IIa	Active

Not available yet.

Not available yet.

Not available yet.

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 19, 2024	Z-2094-2025	—	completed	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.
Jan 19, 2024	Z-2091-2025	—	completed	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.
Jan 19, 2024	Z-2093-2025	—	completed	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.
Jan 19, 2024	Z-2092-2025	—	completed	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.
Jan 19, 2024	Z-2090-2025	—	completed	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.