# K011666: Chillit

- Pathway: 510(k) (Traditional)
- Applicant: Heatshield, Inc.
- Decided: Aug 6, 2001 after 68 days
- Product code: EAT (Tester, Pulp)
- Device class: 2
- Regulation: 21 CFR 872.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K243654: DentalJect (2025), 0 descendants of its own

## Indications for use
1. COOLING HEAT SENSITIVE ORTHODONTIC WIRES 2. TOPICAL ANESTHETIC 3. PULP TEST THE VITALITY OF TEETH

Source page: https://510kreport.com/device/K011666
Methodology: https://510kreport.com/methodology