Manufacturer registered with FDA
Cowellmedi Co., Ltd.
Busan, South Korea. Lists 5 dental device types with FDA across 1 registered establishment, and holds 14 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 11
- 510(k) clearances
- 142004–2025
- Markets registered in
- 91,486 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 9 markets
Where regulators' registries name Cowellmedi Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Cowellmedi Co., Ltd. | 14 clearances | 2004–2025 | Below |
| European Union | EUDAMED | Manufacturer | Cowellmedi Co., Ltd. | 1,377 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | COWELLMEDI CO., LTD. | 79 | 2021–2022 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Cowellmedi Co., Ltd.COWELL MEDI CO., LTD. | 17 | 2006–2021 | Pure Global AI |
| China | NMPA | Registration holder | （株）柯威尔株式会社Cowellmedi co.,Ltd.(株)柯威尔株式会社Cowellmedi Co., Ltd. · （株）柯威尔株式会社 Cowellmedi Co., Ltd. | 4 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | COWELLMEDI CO. LTD.COWELLMEDI CO. LTD | 4 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | COWELLMEDI CO., LTD.COWELLMEDI CO., LTD | 3 | 2019–2019 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Cowellmedi Co., Ltd. | 1 | 2026–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | COWELLMEDI COMPANY LIMITED | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Cowellmedi Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | INNO SLA Mini Plus® Implant SystemINNO SLA Sub Narrow Implant SystemINNO SLA Sub Ti-base SystemINNO SLA Submerged Implant SystemMeta G UCLA AbutmentSFIT Abutment | 2013 |
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | INNO SLA Mini Plus® Implant SystemINNO SLA Sub Narrow Implant SystemINNO SLA Submerged Implant System | 2013 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | — | 2008 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental Implant System_Instrument | 2005 |
| Intraoral Synthetic BarrierNPK · Class 2 | Bone grafts & membranes | Maker | InnoGenic Non-resorbable Membrane | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Cowellmedi Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Sep 2025 | K242287 | SFIT Abutment | NHA Endosseous Dental Implant Abutment |
| 27 Dec 2024 | K241127 | INNO SLA Mini Plus® Implant System | DZE Root-Form Endosseous Implant |
| 20 Dec 2023 | K231411 | INNO SLA Submerged Hybrid Ti-Base System | NHA Endosseous Dental Implant Abutment |
| 21 Nov 2023 | K232546 | Meta G UCLA Abutment | NHA Endosseous Dental Implant Abutment |
| 18 Oct 2023 | K231395 | INNO SLA Submerged Narrow Implant System | DZE Root-Form Endosseous Implant |
| 24 Feb 2023 | K211554 | InnoGenic Non-resorbable Membrane | NPK Intraoral Synthetic Barrier |
| 25 Jan 2022 | K201323 | INNO SLA Submerged Implant System | NHA Endosseous Dental Implant Abutment |
| 6 Dec 2013 | K132242 | INNO SLA SUBMERGED IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 20 Dec 2010 | K100850 | COWELL IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 29 Jul 2009 | K090054 | ATLAS IMPLANT SYSTEM - WIDE PLUS | DZE Root-Form Endosseous Implant |
| 20 Apr 2009 | K090049 | ATLAS IMPLANT SYSTEM- MINI PLUS | DZE Root-Form Endosseous Implant |
| 6 Feb 2008 | K071148 | ATLAS IMPLANT SYSTEM | DZE Root-Form Endosseous Implant |
| 28 Jul 2005 | K050635 | ALLFIM IMPLANT SYSTEMS | DZE Root-Form Endosseous Implant |
| 8 Sep 2004 | K041655 | BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| COWELLMEDI CO., LTD.FDA reg. 3005115116 | BUSAN, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9071264). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.