K250279
- 510(k) number
- K250279
- Device name
- RC-SwiftPrep
- Applicant
- Belport Company, Inc., Gingi-Pak CA · US
- Product code
- KJJ — Cleanser, Root Canal
- Decision date
- 2025-07-02
- Date received
- 2025-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Unknown
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K250279
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.