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FDA 510(k) Applications Submitted by Ki Yoon Nam
FDA 510(k) Number
Submission Date
Device Name
Applicant
K241485
05/24/2024
TruAbutment DS; TruBase
TruAbutment Inc.
K243255
10/15/2024
URIS Long Implant & Abutments
TruAbutment Inc.
K230438
02/21/2023
URIS Smart Path Implant System & Prosthetic
TruAbutment Inc.
K231874
06/26/2023
AOT & T-L Abutment
TruAbutment Inc.
K201124
04/27/2020
TOPAZ Mobile DR System
DRGEM Corporation
K202156
07/27/2020
DIAMOND-5A/6A/8A
DRGEM Corporation
K192364
08/30/2019
GXR-Series Diagnostic X-Ray System
DRGEM Corporation
K202572
09/04/2020
GXR-Series Diagnostic X-Ray System
DRGEM Corporation
K192453
09/09/2019
DIAMOND-5A/6A/8A
DRGEM Corporation
K182537
09/14/2018
RADMAX Digital Imaging Software
DRGEM Corporation
K183292
11/26/2018
Topaz Mobile DR System
DRGEM Corporation
K183388
12/06/2018
JADE Mobile X-Ray
DRGEM Corporation
K101563
06/04/2010
SMARTO
JEIL MEDICAL CORPORATION
K191913
07/17/2019
TruAbutment DS
TruAbutment Inc.
K183106
11/08/2018
TruAbutment DS
TruAbutment Inc.
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