# K972239: Elite H-D Vinyl Polysiloxane Impression Materials .Putty Soft/Normal Setting /Putty Soft/Fast Setting

- Pathway: 510(k) (Traditional)
- Applicant: Zhermack S.P.A.
- Decided: Aug 1, 1997 after 46 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
Elite H-D putties are thick, vinyl polysiloxane dental impression materials intended to be used in conjunction with more fluid vinyl polysiloxane impression materials in order'to make dental 1mpressions. The resulting impressions are used to make plaster models of the teeth.

Source page: https://510kreport.com/device/K972239
Methodology: https://510kreport.com/methodology