# K241354: Sealer Solvent

- Pathway: 510(k) (Traditional)
- Applicant: Inter-Med, Inc.
- Decided: Aug 27, 2024 after 106 days
- Product code: KJJ (Cleanser, Root Canal)
- 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: 2 generations back to K032627 (2003). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063703: Citric Acid 20% Solution, Model 329, Ultradent Products, Inc. (2006) Summary page 5.

## Indications for use
Sealer Solvent, a root canal cleanser, is intended to irrigate, cleanse, and debride root canal systems including the removal of foreign material and debris during root canal therapy.

Source page: https://510kreport.com/device/K241354
Methodology: https://510kreport.com/methodology