# K030884: Aptus Blue

- Pathway: 510(k) (Abbreviated)
- Applicant: Acadental
- Decided: May 27, 2003 after 68 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: 1 generation back to K972234 (1997). 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)
- K972234: RCT Gel Root Canal Therapy Gel, Dentsply Intl. (1997) Summary page 1.
- (no number) RC Prep: named in the summary without a submission number

## Indications for use
Aptus Blue is used in the cleansing of the root canal preparation during endodontic therapy.

Source page: https://510kreport.com/device/K030884
Methodology: https://510kreport.com/methodology