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510(k) K250279

RC-SwiftPrep by Belport Company, Inc., Gingi-Pak — Product Code KJJ

K250279 is an FDA 510(k) premarket notification submitted by Belport Company, Inc., Gingi-Pak for the device "RC-SwiftPrep". The FDA issued a decision of Substantially Equivalent on July 2, 2025. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Belport Company, Inc., Gingi-Pak has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2025
Date Received
January 31, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Root Canal
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Belport Company, Inc., Gingi-Pak

  • K260430 — Porcelain Etch Gel (April 10, 2026)
  • K251775 — RODIN Cement (September 2, 2025)
  • K250222 — SDF Pro (May 7, 2025)
  • K240688 — RODIN Titan 3D Resin (June 20, 2024)
  • K231060 — ProMin Dental Desensitizing Gel (June 13, 2024)
  • K231793 — RODIN 3D Resin SPLINT, Hard/Flex (March 26, 2024)
  • K223365 — RODIN Palette Naturalizing Kit (March 27, 2023)
  • K211420 — Stasis Gel (March 14, 2022)
  • K211419 — Gingi-Aid Gel (January 10, 2022)
  • K200462 — EtchPro Etching Gel (September 2, 2020)

Other clearances for product code KJJ

  • K241354 — Sealer Solvent (August 27, 2024)
  • K201785 — EPIEN Dental Cleanser (September 9, 2021)
  • K211813 — Triton (August 18, 2021)
  • K193357 — V-Mix (October 23, 2020)
  • K193409 — Vista Rinse, Vista Rinse Plus (September 9, 2020)
  • K200330 — RC-Prime Root Canal Preparation Cream (July 6, 2020)
  • K173163 — ChlorCid, ChlorCid V, ChlorCid Surf (February 9, 2018)
  • K162311 — Straumann PrefGel (March 7, 2017)
  • K160577 — PacEndo Chlorhexidine (July 25, 2016)
  • K153528 — PacEndo EDTA (February 1, 2016)

FDA data resources