# K152861: Aquasil Ultra + Smart Wetting Impression Material

- Pathway: 510(k) (Special)
- Applicant: Dentply International, Inc.
- Decided: Mar 4, 2016 after 156 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: 4 generations back to K943574 (1994). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113406: Aquasil  Ultra Smart Wetting Impression Material, Dentsply International, Inc. (2012) Summary page 4.

## Most influential descendants
- K220097: PRESIDENT The Original (2022), 1 descendant of its own
- K242360: Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator (2024), 0 descendants of its own

## Indications for use
Aquasil® Ultra + Smart Wetting® Impression Material is indicated for all dental impression techniques.

Source page: https://510kreport.com/device/K152861
Methodology: https://510kreport.com/methodology