Class Class II
Flexible Partial Resin (K250302)
Description
Flexible Partial Resin by Prismatik Dentalcraft, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250302
Clearance Date2025-06-25
Clearance TypeTraditional
Product CodeEBI
Regulation Number872.3760
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250302
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. Flexible Partial Resin (K250302) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K223798 | Glidewell TuffSplint™ Appliance Resin | Prismatik Dentalcraft, Inc. | 2023 |
| K213994 | Flexible Block | Shandong Huge Dental Material Corpo... | 2022 |
Trace the full predicate network for K250302
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.