Class Class II
LL Implant System (K242379)
Description
LL Implant System by Ossvis Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242379
Clearance Date2024-11-07
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242379
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. LL Implant System (K242379) cites 5 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231079 | LW Retraction Cap | Ossvis Co., Ltd. | 2023 |
| K223924 | LW Implant System | Ossvis Co., Ltd. | 2023 |
| K191201 | EM SA Implant System | Hiossen, Inc. | 2019 |
| K170394 | Kisses Mini | Achimhai Medical Corporation | 2017 |
| K112540 | S-MINI IMPLANT SYSTEM | Neobiotech Co., Ltd. | 2012 |
Trace the full predicate network for K242379
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.