# K190597: BRILLIANT EverGlow Flow

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent AG
- Decided: Jun 21, 2019 after 106 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: 1 generation back to K152927 (2016). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152927: Brilliant Everglow, Coltene/Whaledent AG (2016) Summary page 5.

## Indications for use
BRILLIANT EverGlow Flow Universal and Translucent shades are suitable for: • Direct class V fillings (cervical caries, root erosion, wedge-shaped defects) • Fillings in the anterior tooth region (Class III and IV) • Small fillings of all cavity classes (not occlusion-bearing) • Blocking out of undercuts • Adhesive luting of indirect composite and ceramic restorations in as far as accuracy of fit and light permeability are given • Repairs of direct and indirect composite restorations • Preventive resin restorations • Cavity lining BRILLIANT EverGlow Flow opaque shade is also suitable for: • Aesthetic corrections (e.g. deviations in chroma) • Masking of dark areas

Source page: https://510kreport.com/device/K190597
Methodology: https://510kreport.com/methodology