# K113406: Aquasil  Ultra Smart Wetting Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Feb 13, 2012 after 87 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: 3 generations back to K943574 (1994). 6 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021410: Aquasil Ultra XLV Smart Wetting Impression Material, Dentsply Intl. (2002) Summary page 1.
- K021413: Aquasil Ultra Rigid Smart Wetting Impression Material, Dentsply Intl. (2002) Summary page 1.
- K021416: Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material, Dentsply Intl. (2002) Summary page 1.

## Most influential descendants
- K152615: Vonflex S (2016), 2 descendants of its own
- K152861: Aquasil Ultra + Smart Wetting Impression Material (2016), 2 descendants of its own
- 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
- K233954: Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu (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/K113406
Methodology: https://510kreport.com/methodology