# K262681: NanoCeram Resin

- Pathway: 510(k) (Traditional)
- Applicant: 3BFAB Teknoloji a.S.
- Decided: Jul 31, 2026 after 1 day
- 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: 8 generations back to K901789 (1990). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240688: RODIN Titan 3D Resin, Belport Company, Inc., Gingi-Pak (2024) Summary page 5.
- K230445: OnX Tough, Sprintray, Inc. (2023) Summary page 5.

## Indications for use
NanoCeram Resin is a light-curing 3D printed material designed as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. NanoCeram Resin material is used in the fabrication of permanent restorations such as inlays, onlays, veneers and full crown restorations. NanoCeram 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 denture and preformed denture teeth to be used in a denture.

Source page: https://510kreport.com/device/K262681
Methodology: https://510kreport.com/methodology