# K021416: Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material

- Pathway: 510(k) (Special)
- Applicant: Dentsply Intl.
- Decided: May 13, 2002 after 10 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 K943574 (1994). 1 ancestor in all.
46 later devices descend from it; 4 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K040053: Precision VPS Impression Material (2004), 25 descendants of its own
- K062450: D-Spect Cardiac Scanner System (2006), 14 descendants of its own
- K103164: Vonflex Heavy, Vinflex Light (2010), 13 descendants of its own
- K152766: CharmFlex (2016), 12 descendants of its own
- K170736: HySil Impression Materials (2017), 10 descendants of its own

## Indications for use
Used as impression materials in a dual phase impression technique. They may also be used for precise duplication of models. Use Regular Set for capturing multiple unit impressions. It is suitable for all impression techniques where the operator needs a monophase, heavy, or low viscosity material. Use Fast Set for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

Source page: https://510kreport.com/device/K021416
Methodology: https://510kreport.com/methodology