WARANTEC Co., Ltd.
Seongnam-si Gyeonggi, KR
WARANTEC Co., Ltd. appears in FDA device records in Seongnam-si Gyeonggi, KR. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for WARANTEC Co., Ltd. between 2009 and 2023. The busiest year on record is 2023, with 2. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2018 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K221972 | Warantec Custom Abutment | NHA | Substantially Equivalent | |
| K221969 | IU Implant System Abutment | NHA | Substantially Equivalent | |
| K172345 | IU Implant System | DZE | Substantially Equivalent | |
| K081748 | ONEPLANT DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009514134 | 3009514134 | WARANTEC Co., Ltd. | 411~412, 474, Dunchon-daero, Seongnam-si Gyeonggi 13229 KR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain