# K213339: DENU Composite Resin, DENU Flow Resin

- Pathway: 510(k) (Abbreviated)
- Applicant: Hdi, Inc.
- Decided: Sep 23, 2022 after 351 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 K083610 (2008). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083610: Filtek Supreme Ultra Universal Restorative, 3M Company (2008) Summary page 4.
- K100235: Filtek Supreme Ultra Flowable Restorative, 3M Company (2010) Summary page 4.

## Most influential descendants
- K240823: els extra low shrinkage® composite & els extra low shrinkage® flow (2024), 0 descendants of its own

## Indications for use
DENU Composite Resin is indications for use m: - Core buildup - Splinting DENU Flow Resin is mdications for use in: - Class IMI restorations - Class V restorations - Small Class I restorations (non stress-bearmg restorations) - Pit and fissure sealing in molars and premolars - Repair of small defects in esthetic mdirect mlays

Source page: https://510kreport.com/device/K213339
Methodology: https://510kreport.com/methodology