Class Class II
s-Clean Link Abutment (K222913)
Description
s-Clean Link Abutment by Dentis Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222913
Clearance Date2023-01-13
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222913
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. s-Clean Link Abutment (K222913) cites 4 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210080 | Dentis s-Clean s-Line Mini | Dentis Co., Ltd. | 2021 |
| K210134 | Dentis s-Clean s-Line | Dentis Co., Ltd. | 2021 |
| K181037 | DIO CAD/CAM Abutment | Dio Corporation | 2018 |
| K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED B... | Liaoning Upcera Co., Ltd. | 2014 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K230126 | Dentis s-Clean Regular Abutment | Dentis Co., Ltd. | 2023 |
| K230523 | s-Clean Link Abutment Narrow | Dentis Co., Ltd. | 2023 |
Trace the full predicate network for K222913
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.