# K213765: Glidewell 3DP Denture Base Resin

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Jun 22, 2022 after 203 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: 6 generations back to K011560 (2001). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210298: GR-14 Resin System, Pro3Dure Medical GmbH (2021) Summary page 4.

## Most influential descendants
- K261802: Glidewell™ Denture Base Resin (2026), 0 descendants of its own
- K241493: Glidewell™ 3DP Denture Base Resin (2024), 0 descendants of its own

## Indications for use
Glidewell™ 3DP Denture Base Resin is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment. Glidewell™ 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/K213765
Methodology: https://510kreport.com/methodology