# K972027: Elite H-D Hydrophilic Vinyl Polysiloxane Impression Materials (Light Body/Normal,Light Body/Fast Setting,Regular Body,)

- Pathway: 510(k) (Traditional)
- Applicant: Zhermack S.P.A.
- Decided: Jul 16, 1997 after 44 days
- Product code: ELW (Material, Impression)
- Device class: 2
- Regulation: 21 CFR 872.3660
- Recalls of this device: 2 (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
- Feb 4, 2013 · Class III · Z-0811-2013: Incorrect packaging of regular set and fast set cartridges.
- Feb 4, 2013 · Class III · Z-0812-2013: Incorrect packaging of regular set and fast set cartridges.

## Indications for use
Elite H-D impression products are vinyl polysiloxane dental impression materials intended to be used for making very accurate dental impressions. The resulting impressions are used to make plaster models of the teeth.

Source page: https://510kreport.com/device/K972027
Methodology: https://510kreport.com/methodology