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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 4 of 5

Device	Model / Reference	Registries	Class	Status
ioConnect	IO-GD43M	EUDAMEDFDA UDI	Class I	Active
T-Marker	TM-UR07	EUDAMED	Class I	Active
HS Cap	HS-GD43	EUDAMEDFDA UDI	Class I	Active
ioConnect Kit	IOK-ST35	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-NBS	EUDAMEDFDA UDI	Class I	Active
T-Marker Kit	TMK-ST	EUDAMED	Class I	Active
HS Cap	HS-AG40	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-AG48S	EUDAMEDFDA UDI	Class I	Active
ioConnect Screw	IOW14T(10)	EUDAMED	Class I	Active
HS Cap Small	HSS-AG48	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-ST35L	EUDAMEDFDA UDI	Class I	Active
Tru Driver Hand	TDH-TX15	EUDAMED	Class I	Active
Tru Dual Align Scan Body	AT-DASB(12)	EUDAMED	Class I	Active
ioConnect	IO-ATM	EUDAMEDFDA UDI	Class I	Active
HS Cap Small	HSS-DS	EUDAMEDFDA UDI	Class I	Active
ioConnect Kit	IOK-GD	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-GD47S	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-ST46S	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-DSL	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-ST35M	EUDAMEDFDA UDI	Class I	Active
ioConnect Screw	IOW14TL(10)	EUDAMED	Class I	Active
T-Marker	TM-ST4602	EUDAMED	Class I	Active
ioConnect	IO-URS	EUDAMEDFDA UDI	Class I	Active
ioConnect Screw	IOW172H	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-URM	EUDAMEDFDA UDI	Class I	Active
ioConnect Screw	IOW1602H12(10)	EUDAMED	Class I	Active
T-Marker Screw	TMW-ST46(10)	EUDAMED	Class I	Active
T-Marker Screw	TMW-AT(10)	EUDAMED	Class I	Active
ioConnect Screw	IOW14U	EUDAMEDFDA UDI	Class I	Active
HS Cap Small	HSS-AG40	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-GD43S	EUDAMEDFDA UDI	Class I	Active
ioConnect Screw	IOW16H(10)	EUDAMED	Class I	Active
T-Marker	TM-ST4606	EUDAMED	Class I	Active
ioConnect	IO-GD47L	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-DSS	EUDAMEDFDA UDI	Class I	Active
T-Marker	TM-AT08	EUDAMED	Class I	Active
ioConnect Screw	IOW14H12	EUDAMEDFDA UDI	Class I	Active
ioConnect Screw	IOW14TL	EUDAMEDFDA UDI	Class I	Active
ioConnect Kit	IOK-ST46	EUDAMEDFDA UDI	Class I	Active
T-Marker	TM-ST4607	EUDAMED	Class I	Active
ioConnect Kit	IOK-UR	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-NBL	EUDAMEDFDA UDI	Class I	Active
HS Cap Small	HSS-ZM	EUDAMEDFDA UDI	Class I	Active
Tru Dual Align Scan Body Kit	TDAK01-AT	EUDAMED	Class I	Active
ioConnect Kit	IOK-DS	EUDAMEDFDA UDI	Class I	Active
Tru Dual Align Scan Body	ST-DADW(12)	EUDAMED	Class I	Active
ioConnect Screw	IOW16H	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-ATS	EUDAMEDFDA UDI	Class I	Active
ioConnect Screw	IOW18H	EUDAMEDFDA UDI	Class I	Active
ioConnect Kit	IOK-ST	EUDAMEDFDA UDI	Class I	Active

Related Companies

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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