# K241493: Glidewell™ 3DP Denture Base Resin

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Sep 12, 2024 after 107 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K011560 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213765: Glidewell 3DP Denture Base Resin, Prismatik Dentalcraft, Inc. (2022) Summary page 5.

## Indications for use
Glidewell Tm 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewel TM 3DP Denture Base Resin is indicated for the fabrication and repair, by additive manufacturing, of full and partial removable dentures and baseplates.

Source page: https://510kreport.com/device/K241493
Methodology: https://510kreport.com/methodology