# K200330: RC-Prime Root Canal Preparation Cream

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent, Inc.
- Decided: Jul 6, 2020 after 147 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.
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
RC-Prime Root Canal Preparation Cream is intended to be used by dental practitioners to cleanse and debride root canals for more efficient instrumentation during endodontic therapy.

Source page: https://510kreport.com/device/K200330
Methodology: https://510kreport.com/methodology