Data / Medical devices / United States / Truabutment Inc.

Truabutment Inc.: FDA-registered device maker in Irvine, CA, United States, 10 510(k) clearances

Name: Truabutment Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Truabutment Inc. is registered with the FDA (registration 3012422693) in Irvine, CA, United States. It lists 2 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 9, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3012422693
Address: 17666 Fitch, Irvine, CA, United States, 92614
Owner or operator: TruAbutment Inc. (10053343)
Roles: Manufacturer
First device listed: May 24, 2023
Registered through: 2027
Brand names listed: T-Marker SW, TruAbutment DS, TruAbutment DS, TruBase

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Manufacturer	accessdata.fda.gov
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	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
October 9, 2024	K241485	TruAbutment DS; TruBase	NHA	Substantially Equivalent	Truabutment, Inc.	accessdata.fda.gov
July 14, 2022	K213961	TruAbutment DS, TruBase	NHA	Substantially Equivalent	Truabutment, Inc.	accessdata.fda.gov
September 15, 2021	K203649	TruAbutment DS, TruBase	NHA	Substantially Equivalent	Truabutment, Inc.	accessdata.fda.gov
July 8, 2021	K202579	TruAbutment DS, TruBase	NHA	Substantially Equivalent	Truabutment, Inc.	accessdata.fda.gov
March 26, 2021	K201197	TruAbutment DS, TruBase S	NHA	Substantially Equivalent	Truabutment, Inc.	accessdata.fda.gov
June 19, 2020	K191913	TruAbutment DS	NHA	Substantially Equivalent	Truabutment, Inc.	accessdata.fda.gov
January 29, 2020	K183106	TruAbutment DS	NHA	Substantially Equivalent	Truabutment, Inc.	accessdata.fda.gov
January 23, 2018	K172304	TruAbutment DS	NHA	Substantially Equivalent	Truabutment, Inc.	accessdata.fda.gov
May 25, 2017	K170259	TruAbutment DS	NHA	Substantially Equivalent	Truabutment	accessdata.fda.gov
May 20, 2016	K152559	TruAbutment DS	NHA	Substantially Equivalent	Truabutment	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
December 27, 2023	96246	Class II	Ongoing	Brand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 Model/Catalog Number: CN38-SB Software Version: N/A	Retroactive: Due to defect and quality issues dental scanner may not scan properly/accurately	accessdata.fda.gov

Compare with other makers

Updated March 11, 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.