# K131510: Polydimethylsiloxane Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Blackwell Device Consulting
- Decided: Dec 20, 2013 after 210 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Polydimethylslloxane Impression Material is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models. Regular Set material is used for capturing multiple unit restorations. Fast Set is used for capturing one preparation only(slngle unit crown) and is ideal for double arch dual phase techniques.

Source page: https://510kreport.com/device/K131510
Methodology: https://510kreport.com/methodology