# K243654: DentalJect

- Pathway: 510(k) (Traditional)
- Applicant: Vapocoolshot, Inc.
- Decided: May 30, 2025 after 185 days
- Product code: MLY (Vapocoolant Device)
- Device class: U
- 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 K011666 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011666: Chillit, Heatshield, Inc. (2001) Summary page 5.

## Indications for use
The DentalJect™ is intended for topical application to intact mucous membrane (oral cavity). The DentalJect™ is used to target a minimally sized cooling area for lessening pain associated with injections.

Source page: https://510kreport.com/device/K243654
Methodology: https://510kreport.com/methodology