# K053014: Poly Siloxane Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Clinician'S Choice Dental Products, Inc.
- Decided: Nov 15, 2005 after 20 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Mar 18, 2022 · Class II · Z-1100-2022: Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK

## Indications for use
Device intended to be placed intraorally or on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums.

Source page: https://510kreport.com/device/K053014
Methodology: https://510kreport.com/methodology