# K153249: Pulpdent Solo Flowable Composite with MCP

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Apr 1, 2016 after 144 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: 5 generations back to K933139 (1994). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130223: Rmgi Fill, Pulpdent Corporation (2013) Summary page 4.

## Most influential descendants
- K210045: Activa Presto Pack (2021), 0 descendants of its own

## Indications for use
Pulpdent Solo Flowable Composite with MCP is a fluoride, calcium and phosphate-releasing flowable composite used by dental professionals as a restorative, base and liner.

Source page: https://510kreport.com/device/K153249
Methodology: https://510kreport.com/methodology