Class Class II
Glidewell™ 3DP Denture Base Resin (K241493)
Description
Glidewell™ 3DP Denture Base Resin by Prismatik Dentalcraft, Inc., an FDA 510(k) cleared dental device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241493
Clearance Date2024-09-12
Clearance TypeTraditional
Product CodeEBI
Regulation Number872.3760
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241493
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™ 3DP Denture Base Resin (K241493) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213765 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K261802 | Glidewell™ Denture Base Resin | Prismatik Dentalcraft, Inc. | 2026 |
Trace the full predicate network for K241493
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.