# K133850: Camouflage Nanohybrid Composite (Universal & Flowable)

- Pathway: 510(k) (Traditional)
- Applicant: Prismatik Dentalcraft, Inc.
- Decided: Jun 4, 2014 after 167 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: 2 generations back to K863092 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973221: Composite 168 Restorative System, Dentsply Intl. (1998) Summary page 2.

## Indications for use
The Camouflage NanoHybrid Composite (Universal and Flowable) are indicated for cavity classes I, II, III, IV, V, and VI in anterior and posterior teeth. * May be used as a direct restorative material * May be used for fabrication of inlays and onlays

Source page: https://510kreport.com/device/K133850
Methodology: https://510kreport.com/methodology