# K943574: Capture Impression Material

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Aug 23, 1994 after 32 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
No predicates in its family tree.
60 later devices descend from it; 4 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021416: Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material (2002), 46 descendants of its own
- K970433: Aquasil Rigid Smart Wetting Impression Material (1997), 28 descendants of its own
- K021413: Aquasil Ultra Rigid Smart Wetting Impression Material (2002), 27 descendants of its own
- K040053: Precision VPS Impression Material (2004), 25 descendants of its own
- K973782: Aquasil XLV Smart Wetting Impression Material (1997), 25 descendants of its own

Source page: https://510kreport.com/device/K943574
Methodology: https://510kreport.com/methodology