Class Class II
SIMDA Abutment (K223663)
Description
SIMDA Abutment by Simda Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223663
Clearance Date2023-05-24
Clearance TypeTraditional
Product CodeNHA
Regulation Number872.3630
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223663
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. SIMDA Abutment (K223663) cites 4 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191111 | DD Solid Connect® CAD/CAM Abutments | Dental Direkt GmbH | 2023 |
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | 2022 |
| K140878 | STRAUMANN BONE LEVEL TAPERED IMPLANT | Straumann USA, LLC | 2014 |
| K121995 | TS FIXTURE SYSTEM | Osstem Implant Co., Ltd. | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232271 | SIMDA abutment | Simda Co., Ltd. | 2023 |
Trace the full predicate network for K223663
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.