# K143679: Nuance FLOW

- Pathway: 510(k) (Traditional)
- Applicant: Den-Mat Holdings, LLC
- Decided: May 1, 2015 after 128 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
Longest line of descent: 1 generation back to K990108 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990108: LC Flowfill, S & C Polymer GmbH (1999) Summary page 4.

## Indications for use
nuance® FLOW is recommended for the following types of applications: 1) Direct restorations of anterior or posterior teeth 2) Cavity base/liner 3) Intraoral repairs of fracture crowns/bridges

Source page: https://510kreport.com/device/K143679
Methodology: https://510kreport.com/methodology