Class Class II
LUXEN 5G (K241151)
Description
LUXEN 5G by Dentalmax Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241151
Clearance Date2024-09-30
Clearance TypeTraditional
Product CodeEIH
Regulation Number872.6660
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241151
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. LUXEN 5G (K241151) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K171585 | LUXEN Zr, LUXEN Smile | Dentalmax Co., Ltd. | 2018 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K262074 | Any-Zircos | Mediclus Co., Ltd. | 2026 |
Trace the full predicate network for K241151
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.