# K972234: RCT Gel Root Canal Therapy Gel

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Jun 30, 1997 after 14 days
- Product code: EIC (Syringe, Periodontic, Endodontic, Irrigating)
- Device class: 1
- Regulation: 21 CFR 872.4565
- 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. The FDA summary names its predicate without a number.
- (no number) RC Prep Pre-1976 Device: named in the summary without a submission number

## Most influential descendants
- K030884: Aptus Blue (2003), 0 descendants of its own

## Indications for use
Used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy.

Source page: https://510kreport.com/device/K972234
Methodology: https://510kreport.com/methodology