Class Class II
Integrated Endo System (Meet Endo-II) (K242317)
Description
Integrated Endo System (Meet Endo-II) by Denjoy Dental Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK242317
Clearance Date2025-02-13
Clearance TypeTraditional
Product CodeELC
Regulation Number872.4850
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242317
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. Integrated Endo System (Meet Endo-II) (K242317) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | 2021 |
Trace the full predicate network for K242317
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.