# K113263: Arges Imaging Contrast Spray

- Pathway: 510(k) (Traditional)
- Applicant: Arges Imaging, Inc.
- Decided: Nov 14, 2011 after 10 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- 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 K080882 (2008). 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)
- K080882: Cerec Opti Spray, Sirona Dental Systems GmbH (2008) Summary page 1.

## Indications for use
Arges Imaging Contrast is indicated as a coating medium for optical impressions. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surroundings.

Source page: https://510kreport.com/device/K113263
Methodology: https://510kreport.com/methodology