# K150218: Fill-Up!

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent AG
- Decided: Jun 23, 2015 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K222581: Stela Automix System (2022), 1 descendant of its own
- K242097: DenMat Bulk Fill Composite (2024), 0 descendants of its own
- K222583: Stela Capsule System (2022), 0 descendants of its own

## Indications for use
Fill-Up! is indicated for - direct restoration of class I and II cavities - cavity lining – first layer for class I and II cavities - core build-ups

Source page: https://510kreport.com/device/K150218
Methodology: https://510kreport.com/methodology