# K072622: Standout 2

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corp.
- Decided: Dec 4, 2007 after 78 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) StandOut: named in the summary without a submission number

## Indications for use
StandOut 2 is an impression material system intended for use on all crown and bridge, edentulous, orthodontic and implant impressions.

Source page: https://510kreport.com/device/K072622
Methodology: https://510kreport.com/methodology