TruAbutment Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
17
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1313-2025Class IIBrand Name: TruScan Body, REF CN38-SB Product Name: TruScan Body compatible with CONELOG 3.8 ModeDecember 27, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K243255URIS Long Implant & AbutmentsJuly 3, 2025
K241485TruAbutment DS; TruBaseOctober 9, 2024
K230438URIS Smart Path Implant System & ProstheticDecember 29, 2023
K231874AOT & T-L AbutmentOctober 30, 2023
K213961TruAbutment DS, TruBaseJuly 14, 2022
K203649TruAbutment DS, TruBaseSeptember 15, 2021
K202579TruAbutment DS, TruBaseJuly 8, 2021
K201842TruBase SJune 4, 2021
K201197TruAbutment DS, TruBase SMarch 26, 2021
K200817URIS OMNI Narrow System & ProstheticOctober 7, 2020
K191913TruAbutment DSJune 19, 2020
K183106TruAbutment DSJanuary 29, 2020
K171532TruBase SSeptember 11, 2018
K172100URIS OMNI SystemMay 4, 2018
K172304TruAbutment DSJanuary 23, 2018
K170259TruAbutment DSMay 25, 2017
K152559TruAbutment DSMay 20, 2016