# K973781: Aquasil Easy Mix Putty Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Dec 11, 1997 after 69 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
Longest line of descent: 1 generation back to K781151 (1978). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K781151: Reprosil, Dentsply Intl. (1978) Summary page 1.
- K943574: Capture Impression Material, Dentsply Intl. (1994) Summary page 1.

## Most influential descendants
- K061427: Pre-Impression Conditioning Solution (2006), 0 descendants of its own

## Indications for use
AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL is used as a tray material in a dual phase impression Technique. It is designed for taking multiple unit impressions of teeth and/or oral tissue.

Source page: https://510kreport.com/device/K973781
Methodology: https://510kreport.com/methodology