Data / Medical devices / South Korea / WARANTEC Co., Ltd.
WARANTEC Co., Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 4 510(k) clearances
WARANTEC Co., Ltd. is registered with the FDA (registration 3009514134) in Seongnam-si Gyeonggi, South Korea. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 2, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009514134
- Address
- 411~412, 474, Dunchon-daero Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13229
- Owner or operator
- WARANTEC Co., Ltd. (10039281)
- Roles
- Manufacturer
- First device listed
- December 21, 2011
- Registered through
- 2026
- Brand names listed
- 3500, 5702, 7091, 7092, 7093, 7094, 7095, AD-32 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 |
| 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 |
|---|---|---|---|---|---|---|
| October 2, 2023 | K221972 | Warantec Custom Abutment | NHA | Substantially Equivalent | Warantec Co., Ltd. | accessdata.fda.gov |
| May 12, 2023 | K221969 | IU Implant System Abutment | NHA | Substantially Equivalent | Warantec Co., Ltd. | accessdata.fda.gov |
| June 18, 2018 | K172345 | IU Implant System | DZE | Substantially Equivalent | Warantec Co., Ltd. | accessdata.fda.gov |
| March 27, 2009 | K081748 | ONEPLANT DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Warantec Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Implant, Endosseous, Root-Form
- All makers of Drill, Dental, Intraoral
- All makers of Accessories, Implant, Dental, Endosseous
Updated October 2, 2023. 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.