Cowellmedi

Also known as: INNO, INNO SLA

The implant brand of Cowellmedi Co., Ltd. of South Korea, covering the INNO SLA fixture line.

Key facts

Manufacturer	Cowellmedi Co., Ltd.Verified spec[1]
Country	South KoreaVerified spec[1]
Surface	SLA (sandblasted with large grit, acid-etched) on grade-4 commercially pure titaniumVerified spec[2]
Connection	Internal connection, available in hex and non-hex formsVerified spec[1]
manufacturingCountry	South KoreaVerified spec[3]Country of the FDA-registered device establishment, which may differ from the brand’s home country.

Overview

Cowellmedi sells implants under the INNO name, with the INNO SLA Submerged line the internationally cleared product. The fixture is grade-4 titanium with an SLA surface, offered in hex and non-hex versions. Cowellmedi is also a bone-regeneration research company, so its wider catalogue includes membranes and graft materials sold under related INNO/InnoGenic names — worth separating from the implant itself when reading a quotation.

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) K201323 — INNO SLA Submerged Implant System — U.S. Food & Drug Administration, 2022. Accessed 2026-07-21.
[2]FDA 510(k) K132242 — INNO SLA Submerged Implant System — U.S. Food & Drug Administration, 2013. Accessed 2026-07-21.
[3]openFDA — Device registrations and listings — US Food and Drug Administration. Accessed 2026-07-22.