# K021413: Aquasil Ultra Rigid Smart Wetting Impression Material

- Pathway: 510(k) (Special)
- Applicant: Dentsply Intl.
- Decided: May 10, 2002 after 7 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: 2 generations back to K943574 (1994). 2 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970433: Aquasil Rigid Smart Wetting Impression Material, Dentsply Intl. (1997) Summary page 1.

## Most influential descendants
- K082560: Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact (2008), 17 descendants of its own
- K103164: Vonflex Heavy, Vinflex Light (2010), 13 descendants of its own
- K152766: CharmFlex (2016), 12 descendants of its own
- K133527: Suflex Putty, Suflex Heavy, Suflex Mono, Suflex Light (2014), 12 descendants of its own
- K151262: Hyflex Heavy, Hyflex Mono, Hyflex Light (2015), 11 descendants of its own

## Indications for use
Used as an impression material in a dual phase impression technique. It 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 heavy 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/K021413
Methodology: https://510kreport.com/methodology