# K140512: Ufill Bulk Fill Posterior Flowable Composite

- Pathway: 510(k) (Traditional)
- Applicant: Juno Dentistry LP
- Decided: Jul 2, 2014 after 124 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: 4 generations back to K940459 (1994). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120453: Filtek Bulk Fill Flowable Restorative, 3M Espe Dental Products (2012) Summary page 2.

## Indications for use
UFiII Bulk Fill Posterior Flowable Composite is indicated for use (i) in fillings with layer thicknesses up to 4mm in Class I and II cavities, (ii) in cavity lining- as a first (bottom layer) in Class I and II cavities

Source page: https://510kreport.com/device/K140512
Methodology: https://510kreport.com/methodology