Class Class II
INNO SLA Mini Plus® Implant System (K241127)
Description
INNO SLA Mini Plus® Implant System by Cowellmedi Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241127
Clearance Date2024-12-27
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241127
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. INNO SLA Mini Plus® Implant System (K241127) cites 4 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210161 | AnyOne Onestage Implant System | Megagen Implant Co., Ltd. | 2021 |
| K200827 | LOCATOR R-Tx | Ivory Super Holdco, Incp. | 2020 |
| K112540 | S-MINI IMPLANT SYSTEM | Neobiotech Co., Ltd. | 2012 |
| K083067 | MS SYSTEM | Osstem Implant Co., Ltd. | 2009 |
Trace the full predicate network for K241127
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.