Class Class II
Bone Screw (K251569)
Description
Bone Screw by Osstem Implant Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251569
Clearance Date2025-08-13
Clearance TypeTraditional
Product CodeDZL
Regulation Number872.4880
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251569
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. Bone Screw (K251569) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K201210 | The Micro Screw System, Micro Screw System Basic | Hager& Meisinger GmbH | 2021 |
| K182881 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | 2019 |
| K172354 | OssBuilder System | Osstem Implant Co., Ltd. | 2018 |
Trace the full predicate network for K251569
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.