Class Class II
SD TL Implant System (K250280)
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) NumberK250280
Clearance Date2025-07-23
Clearance TypeTraditional
Product CodeDZE
Regulation Number872.3640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250280
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 (K250280) cites 8 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241703 | SD Implant System | Arum Dentistry Co., Ltd. | 2025 |
| K242753 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025 |
| K240091 | NB Mini Implant System | Arum Dentistry Co., Ltd. | 2024 |
| K231753 | Oneday Implant Abutment | Oneday Biotech Co., Ltd. | 2024 |
| K212702 | IM/ST Fixture System | Guilin Fiteeth Medical Instrument C... | 2022 |
| K213506 | NB 1 SA Implant System | Arum Dentistry Co., Ltd. | 2022 |
| K212517 | Magicore System | Innobiosurg Co., Ltd. | 2021 |
| K193425 | Pre-Milled Blank | Arum Dentistry Co., Ltd. | 2020 |
Trace the full predicate network for K250280
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.