# K171147: REVEAL Bulk

- Pathway: 510(k) (Traditional)
- Applicant: Bisco, Inc.
- Decided: Aug 4, 2017 after 107 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: 2 generations back to K083610 (2008). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141081: Filtek Bulk Fill Posterior Restroative, 3M Espe Dental Products (2014) Summary page 4.

## Indications for use
1) Direct anterior and posterior restorations (including occlusal surfaces) 2) Base/liner under direct restorations 3) Core build-ups 4) Splinting 5) Indirect restorations including inlays, onlays and veneers 6) Restorations of deciduous teeth 7) Extended fissure sealing in molars and premolars 8) Repair of defects in porcelain restorations, enamel, and temporaries

Source page: https://510kreport.com/device/K171147
Methodology: https://510kreport.com/methodology