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.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact