# K240688: RODIN Titan 3D Resin

- Pathway: 510(k) (Traditional)
- Applicant: Belport Company, Inc., Gingi-Pak
- Decided: Jun 20, 2024 after 99 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 K901789 (1990). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230445: OnX Tough, Sprintray, Inc. (2023) Summary page 5.
- K210412: Pac-Dent Ceramic Nanohybrid Resin, Pac-Dent, Inc. (2021) Summary page 5.

## Most influential descendants
- K262681: NanoCeram Resin (2026), 0 descendants of its own

## Indications for use
Rodin Titan 3D Resin is a tooth shade ceramic-hybrid resin used for the fabrication of hybrid denture prosthetics, implant-supported denture prosthetics, monolithic full and partial removable dentures, and preformed denture teeth to be used in a denture. It is indicated as a permanent restorative for both anterior and posterior restorations, including occlusal surfaces. It is used for fabricating permanent restorations such as inlays, onlays, veneers and full crown restorations.

Source page: https://510kreport.com/device/K240688
Methodology: https://510kreport.com/methodology