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TruAbutment Inc.

United States·US-MF-000043448

Last updated September 17, 2026

Information

Country: United States
Address: 17666, Fitch, Irvine, United States
Website: truabutment.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 714 956 1488
PRRC Contact: Donguk Shin
EUDAMED SRN: US-MF-000043448
FDA FEI Number: 3012422693
DUNS Number: 079875622

Catalogue (243)

Page 5 of 5

Device	Model / Reference	Registries	Class	Status
Tru Dual Align Scan Body	ST46-DASB(12)	EUDAMED	Class I	Active
ioConnect Kit	IOK-DS	EUDAMEDFDA UDI	Class I	Active
T-Marker	TM-AT04	EUDAMED	Class I	Active
ioConnect	IO-AG40L	EUDAMEDFDA UDI	Class I	Active
HS Cap Small	HSS-GD47	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-ATL	EUDAMEDFDA UDI	Class I	Active
ioConnect Kit	IOK-NB	EUDAMEDFDA UDI	Class I	Active
ioConnect Screw	IOW14H12S	EUDAMEDFDA UDI	Class I	Active
ioConnect Kit	IOK-AG	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-ST46L	EUDAMEDFDA UDI	Class I	Active
T-Marker	TM-UR05	EUDAMED	Class I	Active
ioConnect	IO-ST35S	EUDAMEDFDA UDI	Class I	Active
Tru Driver Hand	TDH-H1215	EUDAMED	Class I	Active
ioConnect	IO-ZMM	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-NBM	EUDAMEDFDA UDI	Class I	Active
T-Marker	TM-UR03	EUDAMED	Class I	Active
HS Cap	HS-NB	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-AG40S	EUDAMEDFDA UDI	Class I	Active
T-Marker	TM-AT06	EUDAMED	Class I	Active
HS Cap Small	HSS-ST46	EUDAMEDFDA UDI	Class I	Active
HS Cap	HS-ZM	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-GD43L	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-AG40M	EUDAMEDFDA UDI	Class I	Active
T-Marker	TM-UR10	EUDAMED	Class I	Active
ioConnect	IO-AG48M	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-ZMS	EUDAMEDFDA UDI	Class I	Active
Tru Dual Align Scan Body	UR-DAW(6)	EUDAMED	Class I	Active
HS Cap	HS-ST46	EUDAMEDFDA UDI	Class I	Active
ioConnect Screw	IOW14H(10)	EUDAMED	Class I	Active
Tru Driver Hand	TDH-UG15	EUDAMED	Class I	Active
T-Marker	TM-AT07	EUDAMED	Class I	Active
Tru Driver Hand	TDH-H12515	EUDAMED	Class I	Active
ioConnect	IO-AG48L	EUDAMEDFDA UDI	Class I	Active
T-Marker	TM-UR01	EUDAMED	Class I	Active
T-Marker Kit	TMK-UR	EUDAMED	Class I	Active
Tru Dual Align Scan Body Kit	TDAK01-UR	EUDAMED	Class I	Active
ioConnect Screw	IOW18H(10)	EUDAMED	Class I	Active
Tru Driver Hand	TDH-H12510	EUDAMED	Class I	Active
T-Marker	TM-UR06	EUDAMED	Class I	Active
ioConnect Screw	IOW14H12(10)	EUDAMED	Class I	Active
ioConnect	IO-GD47M	EUDAMEDFDA UDI	Class I	Active
Tru Dual Align Scan Body	UR-DADW(6)	EUDAMED	Class I	Active
HS Cap	HS-UR	EUDAMEDFDA UDI	Class I	Active

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FDA Recalls (1)

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
Dec 27, 2023	Z-1313-2025	—	open, classified	Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately