# K032627: Ultradent Citric Acid 10% Solution

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Nov 12, 2003 after 78 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K063703: Citric Acid 20% Solution, Model 329 (2006), 2 descendants of its own
- K241354: Sealer Solvent (2024), 0 descendants of its own
- K123538: Epien Root Canal Cleanser (2013), 0 descendants of its own

## Indications for use
Ultradent Citric Acid 10% Solution is used just prior to obtwtion to etch the canal walls, especially ape to allow optimum seal.

Source page: https://510kreport.com/device/K032627
Methodology: https://510kreport.com/methodology