Data / Medical devices / South Korea / Medimecca Co Ltd
Medimecca Co Ltd: FDA-registered device maker in Seoul, South Korea, 3 510(k) clearances
Medimecca Co Ltd is registered with the FDA (registration 3007649394) in Seoul, South Korea. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 25, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007649394
- Address
- 104, 105, 109, 110, Daeryung Techno Town 3, 115, Gasan digital 2-ro Geumcheon-gu, Seoul, South Korea, 08505
- Owner or operator
- MEDIMECCA CO LTD (10029396)
- Roles
- Manufacturer
- First device listed
- May 10, 2009
- Registered through
- 2026
- Brand names listed
- Arman SEMI KIT, Biothread Dental Implant System, Biothread Dental Implant Systems, CHAORUM Full KIT, CHAORUM Implant System, CHAORUM Implant System - AT Tray (various models), CHAORUM Implant System - Ball Abutment Driver (Various Models), CHAORUM Implant System - Ball Abutment Driver O-ring (Various Models) 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 |
| Bur, Dental | EJL | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Gauge, Depth, Instrument, Dental | EIL | 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 |
|---|---|---|---|---|---|---|
| September 25, 2020 | K202039 | Honorst Implant System | DZE | Substantially Equivalent | Medimecca Co., Ltd. | accessdata.fda.gov |
| January 5, 2017 | K160536 | Chaorum Implant System | DZE | Substantially Equivalent | Medimecca Co., Ltd. | accessdata.fda.gov |
| December 5, 2013 | K131682 | UD IMPLANT SYSTEM | DZE | Substantially Equivalent | Medimecca Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Gauge, Depth, Instrument, Dental
- All makers of Bur, Dental
- All makers of Drill, Dental, Intraoral
Updated September 25, 2020. 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.