# K191427: Halley resin system

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Sirona
- Decided: Aug 26, 2019 after 89 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: 5 generations back to K011560 (2001). 5 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190043: Halley resin, Dentsply Sirona (2019) Summary page 4.

## Most influential descendants
- K231578: Lucitone Digital Print Denture System (2023), 2 descendants of its own
- 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
Halley resin is a light-cured resin indicated for the fabrication of dentures bases in dental laboratories, including full and partial dentures as well as implant overdentures, and other dental appliances. Halley resin can be used as a try-in material for evaluation prior to fabrication of the final restoration. Fabrication of these prostheses require a computer-aided design and manufacturing (CAD/CAM) system using an additive printer. Halley resin can be utilized as an aid in bonding denture base to denture teeth as well as repair using traditional techniques. Halley Denture-Tooth Bonding Agent is indicated for use in enhancing the bond of denture base to denture base. Halley Sealer is a light-cured sealant that produces a smooth, glossy surface finish on the denture.

Source page: https://510kreport.com/device/K191427
Methodology: https://510kreport.com/methodology