# K152927: Brilliant Everglow

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent AG
- Decided: Apr 28, 2016 after 206 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K190597: BRILLIANT EverGlow Flow (2019), 0 descendants of its own

## Indications for use
BRILLIANT EverGlow Bleach (BL), A1/B1, A2/B2, A3/D3, A3,5/B3, C2/C3, A4/C4 are indicated for: - Direct filling of class [, 11, lll, 1V and V cavities - Cementation and repair of composite and ceramic restorations (e.g. COMPONEER) BRILLIANT EverGlow Translucent (Trans) and Bleach Translucent (BL Trans) are indicated for: - Shape and color corrections to enhance the individual esthetics - Reconstruction of incisal edges - Cementation and repair of composite and ceramic restorations (e.g. COMPONEER)

Source page: https://510kreport.com/device/K152927
Methodology: https://510kreport.com/methodology