# K013237: Statusblue

- Pathway: 510(k) (Abbreviated)
- Applicant: Dmg USA, Inc.
- Decided: Oct 22, 2001 after 24 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: 3 generations back to K812116 (1981). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974231: Position Penta, Position Penta Quick, Espe GmbH & Co. Kg. (1998) Summary page 1.

## Indications for use
StatusBlue is indicated for use as a dental impression material in the following applications: Situation impressions of any kind; Impressions for the preparation of provisionals; Impressions for orthodontic models; Impressions of the opposing jaw;, Impressions for the manufacture of model cast dentures

Source page: https://510kreport.com/device/K013237
Methodology: https://510kreport.com/methodology