Class Class II
Customized Abutment (K223634)
Description
Customized Abutment by Arum Dentistry Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223634
Clearance Date2023-04-28
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223634
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. Customized Abutment (K223634) cites 2 predicate devices and is itself cited by 4 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222131 | NB 1 SA Implant System | Arum Dentistry Co., Ltd. | 2022 |
| K193425 | Pre-Milled Blank | Arum Dentistry Co., Ltd. | 2020 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K241703 | SD Implant System | Arum Dentistry Co., Ltd. | 2025 |
| K242753 | SD TL Implant System | Arum Dentistry Co., Ltd. | 2025 |
| K242245 | Customized Abutment | Arum Dentistry Co., Ltd. | 2024 |
| K234112 | Customized Abutment | Arum Dentistry Co., Ltd. | 2024 |
Trace the full predicate network for K223634
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.