# K022097: Thermique

- Pathway: 510(k) (Traditional)
- Applicant: Parkell, Inc.
- Decided: Sep 6, 2002 after 71 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
For use during condensation of gutta percha in tooth root canals. May also be used as a pulp tester to test tooth response to thermal stimulus through molten gutta percha.

Source page: https://510kreport.com/device/K022097
Methodology: https://510kreport.com/methodology