# K210412: Pac-Dent Ceramic Nanohybrid Resin

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent, Inc.
- Decided: Jul 26, 2021 after 165 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K240688: RODIN Titan 3D Resin (2024), 1 descendant of its own
- K262681: NanoCeram Resin (2026), 0 descendants of its own

## Indications for use
Pac-Dent Ceramic Nanohybrid Resin 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/K210412
Methodology: https://510kreport.com/methodology