Class Class II
iTero Lumina™ Pro (K240573)
Description
iTero Lumina™ Pro by Align Technology , Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK240573
Clearance Date2024-08-16
Clearance TypeTraditional
Product CodeNTK
Regulation Number872.1745
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K240573
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. iTero Lumina™ Pro (K240573) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193659 | iTero Element 5D | Align Technology, Inc. | 2020 |
Trace the full predicate network for K240573
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.