# K201795: Transcend

- Pathway: 510(k) (Abbreviated)
- Applicant: Ultradent Product, Inc.
- Decided: Sep 28, 2020 after 90 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K043119 (2004). 1 ancestor in all.
1 later device descends 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)
- K043119: Amelogen Plus, Ultradent Products, Inc. (2004) Summary page 5.

## Most influential descendants
- K262228: Transcend Bulk Fill Flowable Composite (2026), 0 descendants of its own

## Recalls of this device
- Aug 2, 2024 · Class II · Z-3068-2024: Due to a manufacturing issue, red particulates present in the expressed composite.
- Aug 2, 2024 · Class II · Z-3067-2024: Due to a manufacturing issue, red particulates present in the expressed composite.

## Indications for use
Transcend universal composite is used for direct and indirect restorations in both the anterior and posterior regions.

Source page: https://510kreport.com/device/K201795
Methodology: https://510kreport.com/methodology