Class Class U
Glidewell TuffSplint™ Appliance Resin (K223798)
Description
Glidewell TuffSplint™ Appliance Resin by Prismatik Dentalcraft, Inc., an FDA 510(k) cleared unknown device.
Regulatory Information
Device ClassClass Class U
510(k) NumberK223798
Clearance Date2023-02-17
Clearance TypeTraditional
Product CodeMQC
FDA Database
View on FDA DatabasePredicate lineage for K223798
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. Glidewell TuffSplint™ Appliance Resin (K223798) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K183598 | KeyPrint KeySplint Soft | Keystone Industries | 2019 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250302 | Flexible Partial Resin | Prismatik Dentalcraft, Inc. | 2025 |
Trace the full predicate network for K223798
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.