Class Class II
Additively Manufactured Aligner Resin (K251415)
Description
Additively Manufactured Aligner Resin by Aidite (Qinhuangdao) Technology Co., Ltd., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251415
Clearance Date2025-08-27
Clearance TypeTraditional
Product CodeNXC
Regulation Number872.5470
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251415
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. Additively Manufactured Aligner Resin (K251415) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K221022 | NextDent Ortho Flex | Vertex-Dental B.V. | 2022 |
| K212680 | LuxCreo Clear Aligner System | LuxCreo, Inc. | 2022 |
Trace the full predicate network for K251415
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.