TRUABUTMENT INC.

FDA Device Registration & Listing · Irvine, CA, US · Registration 3012422693

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012422693
FEI Number
3012422693
Entity Name
TRUABUTMENT INC.
City/State/Country
Irvine, CA, US
Establishment Address
17666 Fitch, Irvine, CA 92614, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TruAbutment Inc. (Owner Number: 10053343)
Owner / Operator Contact Address
17666 Fitch, Irvine, CA 92614, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

TruAbutment DS TruAbutment DS TruAbutment DS TruAbutment DS TruAbutment DS, TruBase TruAbutment DS, TruBase TruAbutment DS TruAbutment DS T-Marker SW TruAbutment DS TruAbutment DS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-05-24
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-10-17
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-04
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2026-02-27
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-04
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-08-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TruAbutment Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K211871 Faico Medical, LLC FAICO Dental Implant System and CAD/CAM Abutments 2021-11-18

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2018 Implant Direct Sybron Manufacturing, LLC 2
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012422693. Last updated year: 2026. Please use registration number 3012422693 when referencing this establishment in official correspondence.
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