Ossvis Co., Ltd.
Anyang-si Gyeonggi, KR
OSSVIS CO., LTD. appears in FDA device records in Anyang-si Gyeonggi, KR. FDA records list 7 510(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 7 510(k) clearances for Ossvis Co., Ltd. between 2023 and 2024. The busiest year on record is 2024, with 4. The most recent is 2024, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2023 | 3 |
| 2024 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242703 | LW Pre-milled Abutment | NHA | Substantially Equivalent | |
| K242379 | LL Implant System | DZE | Substantially Equivalent | |
| K233808 | LW Narrow Implant System | DZE | Substantially Equivalent | |
| K233167 | LW Implant System – Abutment | NHA | Substantially Equivalent | |
| K231235 | LW UCLA Abutment | NHA | Substantially Equivalent | |
| K231079 | LW Retraction Cap | NHA | Substantially Equivalent | |
| K223924 | LW Implant System | DZE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3025338240 | 3025338240 | OSSVIS CO., LTD. | 6F, 7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si Gyeonggi 14055 KR | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EMLChisel, Bone, Surgical
- EMMChisel, Osteotome, Surgical
- EMKCurette, Surgical, Dental
- OFYDental Implant Surgical Tray
- DZADrill, Dental, Intraoral
- EMJElevator, Surgical, Dental
- EILGauge, Depth, Instrument, Dental
- EJBHandle, Instrument, Dental
- DZEImplant, Endosseous, Root-Form
- DZNInstruments, Dental Hand
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