Class Class I
K5 (K233805)
Description
K5 by Osstem Implant Co., Ltd. Chair Business, an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class I
510(k) NumberK233805
Clearance Date2024-09-03
Clearance TypeTraditional
Product CodeEIA
Regulation Number872.6640
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K233805
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. K5 (K233805) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183347 | K3 | Osstem Implant Co., Ltd. | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251491 | K5 Cart, K5 Mount, K5 Swing | Osstem Implant Company., Ltd. Chair... | 2025 |
Trace the full predicate network for K233805
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.