# K250279: RC-SwiftPrep

- Pathway: 510(k) (Traditional)
- Applicant: Belport Company, Inc., Gingi-Pak
- Decided: Jul 2, 2025 after 152 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 SwiftPrep™ Gel is a root canal cleanser designed to etch, cleanse, and debride root canal walls, while removing smear layers prior to obturation. It facilitates efficient instrumentation and promotes optimal sealing of the canal.

Source page: https://510kreport.com/device/K250279
Methodology: https://510kreport.com/methodology