Data / Medical devices / South Korea / Cybermed Inc.
Cybermed Inc.: FDA-registered device maker in Daejeon, South Korea, 5 510(k) clearances
Cybermed Inc. is registered with the FDA (registration 3003781339) in Daejeon, South Korea. It lists 6 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 7, 2022. 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
- 3003781339
- Address
- 6-26, Yuseong-daero 1205beon-gil, Yuseong-gu, Daejeon, South Korea, 34104
- Owner or operator
- Cybermed Inc. (9048516)
- Roles
- Manufacturer
- First device listed
- February 7, 2002
- Registered through
- 2026
- Brand names listed
- 0.5 Slot Driver, 0.9 Hex Driver, 1.2 Angled Driver, 1.2 Hex Driver, 1.25 Angled Driver, 1.25 Hex Driver, ABT. Profiler, Abutment Screw Driver 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 |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| Template | HWT | 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 |
|---|---|---|---|---|---|---|
| January 7, 2022 | K210039 | CORE1 Implant System | DZE | Substantially Equivalent | Cybermed, Inc. | accessdata.fda.gov |
| December 16, 2011 | K113543 | ONDEMAND3D | LLZ | Substantially Equivalent | Cybermed, Inc. | accessdata.fda.gov |
| March 16, 2007 | K070464 | ONDEMAND3D | LLZ | Substantially Equivalent | Cybermed, Inc. | accessdata.fda.gov |
| May 9, 2006 | K061126 | ACCUREX | LLZ | Substantially Equivalent | Cybermed, Inc. | accessdata.fda.gov |
| February 11, 2005 | K050033 | LUCION | LLZ | Substantially Equivalent | Mevisys Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Template
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Drill, Dental, Intraoral
Updated January 7, 2022. 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.