Class Class II
Laon Ortho (K250198)
Description
Laon Ortho by Laon Medi, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250198
Clearance Date2025-04-23
Clearance TypeTraditional
Product CodePNN
Regulation Number872.5470
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250198
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. Laon Ortho (K250198) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K232564 | Align Studio | Laon Medi, Inc. | 2024 |
| K180941 | Ortho System | 3Shape A/S | 2018 |
Trace the full predicate network for K250198
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.