# K973782: Aquasil XLV Smart Wetting Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Dec 4, 1997 after 62 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.
25 later devices descend from it; 1 cites it directly.
0 of 27 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
- K021410: Aquasil Ultra XLV Smart Wetting Impression Material (2002), 24 descendants of its own
- K082560: Panasil Impression Materials, Including Putty, Binetics, Tray, Monophase and Contact (2008), 17 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
- K170736: HySil Impression Materials (2017), 10 descendants of its own

## Indications for use
Aquasil™ XLV Smart Wetting Impression Material is used as an impression material in a dual phase impression technique. It may also be used for precise duplication of models. Regular Set is used for capturing muitiple unit impressions. It is suitable for all impression techniques where the operator needs an extra low viscosity material. Fast Set is used for capturing one preparation only (single unit crown); ideal for double arch dual phase techniques.

Source page: https://510kreport.com/device/K973782
Methodology: https://510kreport.com/methodology