# K052090: Splash! Impression Material Device

- Pathway: 510(k) (Traditional)
- Applicant: Discus Dental, Inc.
- Decided: Aug 5, 2005 after 3 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: 3 generations back to K943574 (1994). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040053: Precision VPS Impression Material, Discus Dental, Inc. (2004) Summary page 2.
- K030318: P2 Polyether, Heraeus Kulzer, Inc. (2003) Summary page 2.
- K021416: Aquasil Ultra Monophase/Heavy/LV Smart Wetting Impression Material, Dentsply Intl. (2002) Summary page 2.

## Most influential descendants
- K053427: Fresh, Dental Impression Material (2006), 5 descendants of its own
- K171562: Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono (2018), 4 descendants of its own
- K213244: Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) (2022), 3 descendants of its own
- K251724: Remi Impression Material (2026), 1 descendant of its own
- K261888: ClearClub Impression Material (2026), 0 descendants of its own

## Indications for use
Splash!® Dental Impression Material is intended for use with all crowns, bridges, occlusal and dental implant impression techniques to reproduce the structure of a patient's teeth and gums,

Source page: https://510kreport.com/device/K052090
Methodology: https://510kreport.com/methodology