# K210045: Activa Presto Pack

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Sep 22, 2021 after 257 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: 6 generations back to K933139 (1994). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153249: Pulpdent Solo Flowable Composite with MCP, Pulpdent Corporation (2016) Summary page 4.

## Indications for use
ACTIVA PRESTO PACK is intended to be used by dental professionals as a dental filling material for pits, root surface cavities, and Class L, II, III, IV and V restorations. Indications include, but are not limited to, direct anterior and posterior restorations (including occlusal surfaces), core build-ups, splinting, and indirect restorations including crowns, inlays, onlays and veneers.

Source page: https://510kreport.com/device/K210045
Methodology: https://510kreport.com/methodology