Class Class II
SD TL Implant System (K242753)
Description
SD TL Implant System by Arum Dentistry Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242753
Clearance Date2025-01-06
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242753
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. SD TL Implant System (K242753) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222778 | Osstem Implant System | Osstem Implant Co., Ltd. | 2023 |
| K222792 | SNUCONE Tissue Level Implant System | Snucone Co., Ltd. | 2023 |
| K223634 | Customized Abutment | Arum Dentistry Co., Ltd. | 2023 |
| K153268 | NR Line Implant System | Dentium Co., Ltd. | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250280 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025 |
Trace the full predicate network for K242753
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.