Cowellmedi INNO SLA Submerged
Also known as: INNO SLA Submerged, INNO Implant
A bone-level submerged implant from Cowellmedi with an SLA surface and a hex/non-hex internal connection.
Quick facts
| Manufacturer | Cowellmedi Co., Ltd.Verified spec[1] |
|---|---|
| Implant level | Bone-level (submerged)Verified spec[1] |
| Material | Grade-4 commercially pure titanium (ASTM F67)Verified spec[1] |
| Surface | SLA — sandblasted with large grit and acid-etchedVerified spec[1] |
| Connection | Internal connection, available in hex and non-hex formsVerified spec[2] |
| Available diameters | Ø3.7, 4.2, 4.6, 5.1 and 6.0 mmVerified spec[1] |
| Available lengths | 7.0, 7.5, 8, 9.5, 10, 11.5, 12 and 14 mm (availability varies by diameter)Verified spec[1] |
Overview
Technology
Further detail
| Country | South KoreaVerified spec[1] |
|---|
Clinical evidence
We have not yet completed a system-specific evidence review for Cowellmedi INNO SLA Submerged. Insufficient system-specific evidence How we grade evidence
Similar implant systems
The clearances below are held by Cowellmedi at brand level and cover its implant range, not Cowellmedi INNO SLA Submerged specifically. We show them here because that is the level at which regulators actually issue them.
Regulatory record
Read this before drawing conclusions. A clearance or certificate means a device may legally be sold in a market. It is not a finding that the implant performs well, and it is not a comparison against other implants. In particular, FDA "clearance" is not FDA "approval" — clearance means the FDA accepted the device as substantially equivalent to one already on the market. What these actually mean →
FDA 510(k) clearance5 records
Cleared as substantially equivalent to a predicate device. Not an FDA approval, and not a finding of safety or effectiveness.
| Number | Device | Holder | Date |
|---|---|---|---|
| K241127 | INNO SLA Mini Plus® Implant System | Cowellmedi Co., Ltd. | 2024-12-27 |
| K231411 | INNO SLA Submerged Hybrid Ti-Base System | Cowellmedi Co., Ltd. | 2023-12-20 |
| K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023-10-18 |
| K201323 | INNO SLA Submerged Implant System | Cowellmedi Co., Ltd. | 2022-01-25 |
| K132242 | INNO SLA SUBMERGED IMPLANT SYSTEM | Cowellmedi Co., Ltd. | 2013-12-06 |
Other2 records
Registered device establishment in South Korea. Registration records where a device is made or handled; it is not a clearance, an approval, or any assessment of the product.
| Number | Device | Holder | Date |
|---|---|---|---|
| 3005115116 | — | COWELLMEDI CO., LTD. | — |
| 115 device records | — | Cowellmedi | — |
Clearance records for Cowellmedi were retrieved from the issuing authority's own database, not from the manufacturer's marketing material. We attribute a clearance to a brand only when the filing holder belongs to that brand's corporate family — third-party clearances for compatible components are excluded, because they belong to the company that made the component, not to Cowellmedi.
Sources
Numbers match the citations beside each claim above.
Primary sources
- [1]FDA 510(k) K132242 — INNO SLA Submerged Implant System — U.S. Food & Drug Administration, 2013. Accessed 2026-07-21.
- [2]FDA 510(k) K201323 — INNO SLA Submerged Implant System — U.S. Food & Drug Administration, 2022. Accessed 2026-07-21.