Data / Medical devices / South Korea / Ossvis Co., Ltd.
Ossvis Co., Ltd.: FDA-registered device maker in Anyang-si Gyeonggi, South Korea, 7 510(k) clearances
Ossvis Co., Ltd. is registered with the FDA (registration 3025338240) in Anyang-si Gyeonggi, South Korea. It lists 12 device types. The FDA files 7 510(k) clearances under its listings, the newest dated December 5, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3025338240
- Address
- 6F, 7F and B1, 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si Gyeonggi, South Korea, 14055
- Owner or operator
- Ossvis Co., Ltd. (10086315)
- Roles
- Manufacturer
- First device listed
- October 30, 2022
- Registered through
- 2026
- Brand names listed
- 1.2 Ball HEX Driver Wrench, 1.2 Hex Driver Engine, 1.2 Hex Driver Wrench, Bone Profile Drill, Bone Profile Guide Pin, Bone Splitter 1, Bone Splitter 2, Bone Tack Carrier 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 |
| Chisel, Bone, Surgical | EML | 1 | Manufacturer | accessdata.fda.gov |
| Chisel, Osteotome, Surgical | EMM | 1 | Manufacturer | accessdata.fda.gov |
| Curette, Surgical, Dental | EMK | 1 | Manufacturer | accessdata.fda.gov |
| Dental Implant Surgical Tray | OFY | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Elevator, Surgical, Dental | EMJ | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 1 | Manufacturer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | 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 |
|---|---|---|---|---|---|---|
| December 5, 2024 | K242703 | LW Pre-milled Abutment | NHA | Substantially Equivalent | Ossvis Co., Ltd. | accessdata.fda.gov |
| November 7, 2024 | K242379 | LL Implant System | DZE | Substantially Equivalent | Ossvis Co., Ltd. | accessdata.fda.gov |
| July 31, 2024 | K233808 | LW Narrow Implant System | DZE | Substantially Equivalent | Ossvis Co., Ltd. | accessdata.fda.gov |
| March 25, 2024 | K233167 | LW Implant System Abutment | NHA | Substantially Equivalent | Ossvis Co., Ltd. | accessdata.fda.gov |
| September 15, 2023 | K231235 | LW UCLA Abutment | NHA | Substantially Equivalent | Ossvis Co., Ltd. | accessdata.fda.gov |
| September 14, 2023 | K231079 | LW Retraction Cap | NHA | Substantially Equivalent | Ossvis Co., Ltd. | accessdata.fda.gov |
| August 8, 2023 | K223924 | LW Implant System | DZE | Substantially Equivalent | Ossvis Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Gauge, Depth, Instrument, Dental
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Instruments, Dental Hand
- All makers of Curette, Surgical, Dental
- All makers of Implant, Endosseous, Root-Form
Updated December 5, 2024. 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.