Data / Medical devices / South Korea / Sewon Medix, Inc.
Sewon Medix, Inc.: FDA-registered device maker in Busan, South Korea, 2 510(k) clearances
Sewon Medix, Inc. is registered with the FDA (registration 3013271380) in Busan, South Korea. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 7, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013271380
- Address
- #29, Sasang-ro, 375 beon-gil, Sasang-gu, Busan, South Korea, 46946
- Owner or operator
- Sewon Medix, Inc. (10053110)
- Roles
- Manufacturer
- First device listed
- November 1, 2016
- Registered through
- 2027
- Brand names listed
- BIOTHREAD BT3 Implant System, BONE TRIMMER (SBT50), DEPTH GAUGE(SDG), DRILL STOPPER(DS507, DS508, DS510, DS511, DS513, DS515, DS607, DS608, DS610, DS611, DS613, DS615), DRIVER CONNECTOR(DCS100, DCM120), Depth Gauge, Drill & Drill Accessories (Guide Drill, Drill Extension, Twist Drill, Pilot Drill, Cortical Drill, Drill Stopper), Drill & Drill Accessories (Sidecut Drill, Bone Profiler, Trephine Drill) 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 |
| Applicator, Resin | KXR | 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 |
|---|---|---|---|---|---|---|
| July 7, 2023 | K222707 | IH Implant System | DZE | Substantially Equivalent | Sewonmedix, Inc. | accessdata.fda.gov |
| October 14, 2016 | K153521 | IH Implant System | DZE | Substantially Equivalent | Sewonmedix, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Applicator, Resin
- All makers of Drill, Dental, Intraoral
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Gauge, Depth, Instrument, Dental
Updated July 7, 2023. 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.