Data / Medical devices / South Korea / Cowellmedi Co., Ltd.
Cowellmedi Co., Ltd.: FDA-registered device maker in Busan, South Korea, 8 510(k) clearances
Cowellmedi Co., Ltd. is registered with the FDA (registration 3005115116) in Busan, South Korea. It lists 6 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 16, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005115116
- Address
- 48, Hakgam-daero 221beon-gil Sasang-Gu, Busan, South Korea, 46986
- Owner or operator
- COWELLMEDI CO., LTD. (9071264)
- Roles
- Manufacturer
- First device listed
- April 5, 2005
- Registered through
- 2027
- Brand names listed
- Dental Implant System_Instrument, INNO SLA Mini Plus® Implant System, INNO SLA Sub Narrow Implant System, INNO SLA Sub Ti-base System, INNO SLA Submerged Implant System, InnoGenic Non-resorbable Membrane, KAPD13L, Meta G UCLA Abutment 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 |
| Barrier, Synthetic, Intraoral | NPK | 2 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Screwdriver, Surgical | LRZ | 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 |
|---|---|---|---|---|---|---|
| September 16, 2025 | K242287 | SFIT Abutment | NHA | Substantially Equivalent | Cowellmedi Co., Ltd. | accessdata.fda.gov |
| December 27, 2024 | K241127 | INNO SLA Mini Plus® Implant System | DZE | Substantially Equivalent | Cowellmedi Co., Ltd. | accessdata.fda.gov |
| December 20, 2023 | K231411 | INNO SLA Submerged Hybrid Ti-Base System | NHA | Substantially Equivalent | Cowellmedi Co., Ltd. | accessdata.fda.gov |
| November 21, 2023 | K232546 | Meta G UCLA Abutment | NHA | Substantially Equivalent | Cowellmedi Co., Ltd. | accessdata.fda.gov |
| October 18, 2023 | K231395 | INNO SLA Submerged Narrow Implant System | DZE | Substantially Equivalent | Cowellmedi Co., Ltd. | accessdata.fda.gov |
| February 24, 2023 | K211554 | InnoGenic Non-resorbable Membrane | NPK | Substantially Equivalent | Cowellmedi Co., Ltd. | accessdata.fda.gov |
| January 25, 2022 | K201323 | INNO SLA Submerged Implant System | NHA | Substantially Equivalent | Cowellmedi Co., Ltd. | accessdata.fda.gov |
| December 6, 2013 | K132242 | INNO SLA SUBMERGED IMPLANT SYSTEM | DZE | Substantially Equivalent | Cowellmedi Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Screwdriver, Surgical
- 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
- All makers of Barrier, Synthetic, Intraoral
Updated September 16, 2025. 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.