# K151088: DMRC Bulk Fill

- Pathway: 510(k) (Traditional)
- Applicant: Danville Materials, LLC
- Decided: Aug 28, 2015 after 127 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K242097: DenMat Bulk Fill Composite (2024), 0 descendants of its own

## Indications for use
DMRC Bulk Fill is a dual-cure (auto-cure) with light-cure acceleration) polymer-based dental restoratives that when applied to dental surfaces pretreated with suitable primers or adhesives are indicated for use as the first increment under posterior composites; for core build-ups; and for luting posts, crowns, veneers and any application where light transmission may be inadequate

Source page: https://510kreport.com/device/K151088
Methodology: https://510kreport.com/methodology