# K080882: Cerec Opti Spray

- Pathway: 510(k) (Traditional)
- Applicant: Sirona Dental Systems GmbH
- Decided: Apr 11, 2008 after 11 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K113263: Arges Imaging Contrast Spray (2011), 0 descendants of its own
- K103586: Ios Fastscan Spray (2011), 0 descendants of its own

## Indications for use
CEREC Opti Spray is indicated as a coating medium for optical impressions with the CEREC system. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surrounding.

Source page: https://510kreport.com/device/K080882
Methodology: https://510kreport.com/methodology