# K061427: Pre-Impression Conditioning Solution

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jun 26, 2006 after 34 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: 6 generations back to K931812 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023776: Xeno Iii Dental Adhesive, Dentsply Intl. (2003) Summary page 1.
- K983966: Nupro Prophylaxis Paste with Flouride and Triclosan, Dentsply Intl. (1999) Summary page 1.
- K940685: Pretreatment Solution, Dentsply Intl. (1994) Summary page 1.
- K973781: Aquasil Easy Mix Putty Impression Material, Dentsply Intl. (1997) Summary page 1.

## Indications for use
Preparation conditioning solution for uniform surface wetting prior to elastomeric impression procedures

Source page: https://510kreport.com/device/K061427
Methodology: https://510kreport.com/methodology