# K112168: Componeer

- Pathway: 510(k) (Traditional)
- Applicant: Coltene/Whaledent AG
- Decided: Nov 21, 2011 after 116 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
- K191385: Brilliant Componeer (2019), 0 descendants of its own

## Indications for use
COMPONEER are polymerised, radio-opaque composite shells that are indicated for -restoration therapy for caries -optimisation of old restorations -tooth fractures -extending incisors -malpdsitioned teeth -tooth discoloration, incorrect shading -anatomical malformation -diasteme -attrition, abrasion, erosion -cosmetic correction

Source page: https://510kreport.com/device/K112168
Methodology: https://510kreport.com/methodology