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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 3 of 5

Device	Model / Reference	Registries	Class	Status
TruAbutment DS	NSN-CS	FDA UDI	Class II	Active
TruAbutment DS	CN50-CS	FDA UDI	Class II	Active
TruAbutment DS	NDG-CS	FDA UDI	Class II	Active
TruAbutment DS	AE36-CB	FDA UDI	Class II	Active
TruAbutment DS	NRN-CB	FDA UDI	Class II	Active
TruAbutment DS	CA38-CB	FDA UDI	Class II	Active
TruAbutment DS	CA33-CS	FDA UDI	Class II	Active
TruAbutment DS	SBR-CB	FDA UDI	Class II	Active
TruAbutment DS	IDL30-CB	FDA UDI	Class II	Active
TruAbutment DS	NSR-CS	FDA UDI	Class II	Active
TruAbutment DS	NSR-CB	FDA UDI	Class II	Active
TruAbutment DS	SBN-CB	FDA UDI	Class II	Active
TruAbutment DS	CA43-CB	FDA UDI	Class II	Active
TruAbutment DS	DUR-CS	FDA UDI	Class II	Active
TruAbutment DS	DUR-CB	FDA UDI	Class II	Active
TruAbutment DS	NAR-CS	FDA UDI	Class II	Active
Tru Dual Align Scan Body	AT-DADW(12)	EUDAMED	Class I	Active
T-Marker	TM-AT05	EUDAMED	Class I	Active
ioConnect Screw	IOW18H12	EUDAMEDFDA UDI	Class I	Active
ioConnect Screw	IOW14T	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-URL	EUDAMEDFDA UDI	Class I	Active
HS Cap	HS-AT	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-DSM	EUDAMEDFDA UDI	Class I	Active
ioConnect Screw	IOW14H	EUDAMEDFDA UDI	Class I	Active
ioConnect	IO-ZML	EUDAMEDFDA UDI	Class I	Active
HS Cap Small	HSS-NB	EUDAMEDFDA UDI	Class I	Active
T-Marker Screw	TMW-ST35(10)	EUDAMED	Class I	Active
T-Marker	TM-AT03	EUDAMED	Class I	Active
T-Marker	TM-UR09	EUDAMED	Class I	Active
ioConnect	IO-ST46M	EUDAMEDFDA UDI	Class I	Active
HS Cap Small	HSS-DIO	EUDAMED	Class I	Active
HS Cap	HS-DS	EUDAMEDFDA UDI	Class I	Active
HS Cap	HS-AG48	EUDAMEDFDA UDI	Class I	Active
T-Marker Screw	TMW-UR(10)	EUDAMED	Class I	Active
HS Cap Small	HSS-AT	EUDAMEDFDA UDI	Class I	Active
TruBase S	K201842	FDA 510(k)	Class II	Active
TruBase S	K171532	FDA 510(k)	Class II	Active
URIS OMNI Narrow System & Prosthetic	K200817	FDA 510(k)	Class II	Active
URIS OMNI System	K172100	FDA 510(k)	Class II	Active
URIS Long Implant & Abutments	K243255	FDA 510(k)	Class II	Active
TruAbutment DS, TruBase	K203649	FDA 510(k)	Class II	Active
TruAbutment DS, TruBase	K213961	FDA 510(k)	Class II	Active
TruAbutment DS, TruBase S	K201197	FDA 510(k)	Class II	Active
URIS Smart Path Implant System & Prosthetic	K230438	FDA 510(k)	Class II	Active
AOT & T-L Abutment	K231874	FDA 510(k)	Class II	Active
TruAbutment DS; TruBase	K241485	FDA 510(k)	Class II	Active
TruAbutment DS, TruBase	K202579	FDA 510(k)	Class II	Active
HS Cap Small	HSS-GD43	EUDAMEDFDA UDI	Class I	Active
Tru Dual Align Scan Body	UR-DASB(6)	EUDAMED	Class I	Active
HS Cap Small	HSS-ST35	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