# K231578: Lucitone Digital Print Denture System

- Pathway: 510(k) (Abbreviated)
- Applicant: Dentsply Sirona
- Decided: Oct 20, 2023 after 142 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). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191427: Halley resin system, Dentsply Sirona (2019) Summary page 5.
- K051707: Eclipse Bonding Agent, Dentsply Intl. (2005) Summary page 5.

## Most influential descendants
- K262300: Denture Base Resin V2 (2026), 0 descendants of its own
- K243336: Lucitone Digital Print Denture™ System (2024), 0 descendants of its own

## Indications for use
* Lucitone Digital Print TM 3D Denture Base is a light-cured resin indicated for the fabrication of denture bases including full and partial dentures and implant overdentures, and implant overdentures and other dental appliances. * Lucitone Digital ValueT 3D Economy Tooth & Trial Placement is used as a try-in material for evaluation prior to fabrication of the final restoration or a temporary denture. * Lucitone Digital IPNTr 3D Premium Tooth is a light-cured resin intended for printing denture teeth. * Lucitone Digital ValueT 3D Economy Tooth & Trial Placement is intended for printing full arch and tooth segments. * Lucitone Digital FuseT r 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 FuseTM 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 FuseTM Step 3 - Total 3D Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.

Source page: https://510kreport.com/device/K231578
Methodology: https://510kreport.com/methodology