# K262228: Transcend Bulk Fill Flowable Composite

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Jul 1, 2026 after 1 day
- 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
Longest line of descent: 2 generations back to K043119 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201795: Transcend, Ultradent Product, Inc. (2020) Summary page 6.
- K231817: AlignerFlow LC, Voco GmbH (2023) Summary page 6.

## Indications for use
Transcend™ Bulk-Fill flowable composite is used for: * Direct and indirect restorations in both the anterior and posterior regions * Fabrication of orthodontic attachments for aligners and bonding of lingual retainers

Source page: https://510kreport.com/device/K262228
Methodology: https://510kreport.com/methodology