# K191385: Brilliant Componeer

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent AG
- Decided: Oct 29, 2019 after 159 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 K112168 (2011). 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)
- K112168: Componeer, Coltene/Whaledent AG (2011) Summary page 4.

## Indications for use
BRILLIANT COMPONEER is indicated for: Clinical indications - Restoration of caries defects - Reconstruction of lost tooth substance due to attrition, abrasion, erosion - Restoration of tooth fractures - Correction of anatomical malformation Cosmetic indications - Optimization of old composite restorations - Extending incisors - Correction of malpositioned teeth - Cosmetic corrections for tooth discoloration or incorrect shading - Closure of diastema

Source page: https://510kreport.com/device/K191385
Methodology: https://510kreport.com/methodology