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510(k) K241354

Sealer Solvent by Inter-Med, Inc. — Product Code KJJ

K241354 is an FDA 510(k) premarket notification submitted by Inter-Med, Inc. for the device "Sealer Solvent". The FDA issued a decision of Substantially Equivalent on August 27, 2024. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Inter-Med, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 2024
Date Received
May 13, 2024
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 Inter-Med, Inc.

  • K253337 — REGEN Bioactive Cement (April 15, 2026)
  • K241489 — ReminGel (January 8, 2025)
  • K241457 — Vista BC Putty (August 28, 2024)
  • K221811 — Vista BC Sealer (November 21, 2022)
  • K211721 — PS System (December 2, 2021)
  • K112250 — CHX=CHX PLUS (October 28, 2011)
  • K082470 — SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE (April 3, 2009)
  • K871291 — AM CATH ESWL STENT (April 30, 1987)
  • K864669 — AM CATH ESWL STENT (January 5, 1987)
  • K851922 — URETERAL STONE DISLODGER (August 2, 1985)

Other clearances for product code KJJ

  • K250279 — RC-SwiftPrep (July 2, 2025)
  • 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