Data / Medical devices / South Korea / TruAbutment Korea Co., Ltd.
TruAbutment Korea Co., Ltd.: FDA-registered device maker in Bucheon-si Gyeonggi, South Korea, 17 510(k) clearances
TruAbutment Korea Co., Ltd. is registered with the FDA (registration 3012422333) in Bucheon-si Gyeonggi, South Korea. It lists 6 device types. The FDA files 17 510(k) clearances under its listings, the newest dated July 3, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3012422333
- Address
- ~216, ~1309, 397, Seokcheon-ro, Bucheon-si Gyeonggi, South Korea, 14449
- Owner or operator
- TRUABUTMENT KOREA CO., LTD. (10052347)
- Roles
- Manufacturer
- First device listed
- July 19, 2016
- Registered through
- 2027
- Brand names listed
- AOT & T-L Abutment, AOT Conversion Scan Body, AOT Delivery Tool, AOT Digital Analog, AOT HS Cap Screw, AOT Lab Analog, AOT Plus Conversion Scan, AOT Plus Digital Analog and more
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 |
| Attachment, Precision, All | EGG | 1 | Manufacturer | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | 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 |
|---|---|---|---|---|---|---|
| July 3, 2025 | K243255 | URIS Long Implant & Abutments | DZE | Substantially Equivalent | Truabutment, Inc. | accessdata.fda.gov |
| October 9, 2024 | K241485 | TruAbutment DS; TruBase | NHA | Substantially Equivalent | Truabutment, Inc. | accessdata.fda.gov |
| December 29, 2023 | K230438 | URIS Smart Path Implant System & Prosthetic | DZE | Substantially Equivalent | Truabutment, Inc. | accessdata.fda.gov |
| October 30, 2023 | K231874 | AOT & T-L Abutment | 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 |
| June 4, 2021 | K201842 | TruBase S | NHA | Substantially Equivalent | Truabutment, Inc. | accessdata.fda.gov |
| March 26, 2021 | K201197 | TruAbutment DS, TruBase S | NHA | Substantially Equivalent | Truabutment, Inc. | accessdata.fda.gov |
| October 7, 2020 | K200817 | URIS OMNI Narrow System & Prosthetic | DZE | 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 |
| September 11, 2018 | K171532 | TruBase S | NHA | Substantially Equivalent | Truabutment, Inc. | accessdata.fda.gov |
| May 4, 2018 | K172100 | URIS OMNI System | DZE | 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 |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Attachment, Precision, All
- All makers of Bur, Dental
- All makers of Drill, Dental, Intraoral
- All makers of Accessories, Implant, Dental, Endosseous
Updated July 3, 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.