# K970433: Aquasil Rigid Smart Wetting Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Mar 27, 1997 after 50 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.
28 later devices descend from it; 1 cites 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)
- K943574: Capture Impression Material, Dentsply Intl. (1994) Summary page 1.

## Most influential descendants
- K021413: Aquasil Ultra Rigid Smart Wetting Impression Material (2002), 27 descendants of its own
- 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

## Indications for use
AQUASIL™ RIGID Regular Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV (light viscosity) Impression Material (K943574) in a dual phase impression Technique. The combination is ideal for the double arch (Caulk® First Bite™ Trays) dual phase technique. The combination may alseo be used for precise duplications of models. AQUASIL™ RIGID Fast Set SMART WETTING IMPRESSION MATERIAL is designed as a firm tray material. It is designed to be used with Aquasil™ LV Fast Set Impression Material in a dual phase impression Technique, capturing one or two adjacent preparations. The combination is ideal for the double arch (Caulk® First Bite™ Trays) dual phase technique. The combination may also be used for precise duplications of models.

Source page: https://510kreport.com/device/K970433
Methodology: https://510kreport.com/methodology