# K243336: Lucitone Digital Print Denture™ System

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona, Inc.
- Decided: Dec 17, 2024 after 54 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). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231578: Lucitone Digital Print Denture System, Dentsply Sirona (2023) Summary page 5.
- K192806: DENTCA Crown and Bridge, Dentca, Inc. (2020) Summary page 5.

## Indications for use
* Lucitone Digital Print™ 3D Denture Base is a light-cured resin indicated for the fabrication of denture bases including full and partial dentures* and implant overdentures. * Lucitone Digital IPN™ 3D Premium Tooth is a light-cured resin intended for printing denture teeth. Lucitone Digital Value™ 3D Economy Tooth & Trial Placement is intended for use as: * Printing resin for fabricating removable dentures for try-in and evaluation prior to fabrication of the final denture.* * Printing resin for fabricating a temporary denture. * Printing resin for fabricating denture teeth in full arches and segments that will subsequently be fused into a denture base. * Printing resin for fabricating provisional crowns, bridges.** * Lucitone Digital Fuse™ Step 1 — 3D Tooth Conditioning Agent is indicated for use in enhancing the bond of denture teeth to denture base and denture base to denture base. * Lucitone Digital Fuse™ Step 2 — 3D Denture Bonding Resin is utilized as an aid in bonding denture teeth to denture base as well as repair using traditional techniques. * Lucitone Digital Fuse™ Step 3 — Total 3D Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture. *Partial and full dentures are replacement for patients with missing teeth.† **For instructions on printing provisional crowns and bridges with Lucitone Digital Value reference Section G in IFU †Statement added for EU MDR alignment.

Source page: https://510kreport.com/device/K243336
Methodology: https://510kreport.com/methodology