510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K250279Substantially Equivalent

RC-SwiftPrep

Belport Company, Inc., Gingi-Pak, Camarillo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K250279 is the FDA 510(k) clearance record for RC-SwiftPrep, cleared for Belport Company, Inc., Gingi-Pak on under FDA product code KJJ (Cleanser, Root Canal). FDA records list 11 510(k) clearances for Belport Company, Inc., Gingi-Pak, from to . As of , FDA records show no recalls naming K250279.

Clearance record

Decision date
Received
(152 days to decision)
Product code
KJJ Cleanser, Root Canal
Device class
Unclassified
Review panel
Unknown
Applicant
Belport Company, Inc., Gingi-Pak 4825 Calle Alto, Camarillo CA
510(k) summary
Statement
Third party review
No

Clearances, product code KJJ

Trailing 12 months

FDA records hold no clearances under product code KJJ in the trailing twelve months.

FDA records show no clearances under product code KJJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KJJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260