Cleared Traditional

RC-SwiftPrep

K250279 · Belport Company, Inc., Gingi-Pak · Dental
Jul 2025
Decision
152d
Days
—
Risk

About This 510(k) Submission

K250279 is an FDA 510(k) clearance for the RC-SwiftPrep, a Cleanser, Root Canal, submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on July 2, 2025, 152 days after receiving the submission on January 31, 2025. This device falls under the Dental review panel.

Submission Details

510(k) Number K250279 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2025
Decision Date July 02, 2025
Days to Decision 152 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KJJ — Cleanser, Root Canal
Device Class —