# K012767: S & C Hydro Vinyl Polysiloxane Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: S & C Polymer GmbH
- Decided: Nov 1, 2001 after 76 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
S & C Hydro Vinyl Polysiloxane Impression Material is intended to be placed into a syringe for delivery around a tooth or on a preformed impression tray for placement in the mouth, and used to reproduce the structure of a patient’s teeth and gums.

Source page: https://510kreport.com/device/K012767
Methodology: https://510kreport.com/methodology