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510(k) K112250

CHX=CHX PLUS by Inter-Med, Inc. — Product Code KJJ

K112250 is an FDA 510(k) premarket notification submitted by Inter-Med, Inc. for the device "CHX=CHX PLUS". The FDA issued a decision of Substantially Equivalent on October 28, 2011. 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
October 28, 2011
Date Received
August 4, 2011
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)
  • K241354 — Sealer Solvent (August 27, 2024)
  • K221811 — Vista BC Sealer (November 21, 2022)
  • K211721 — PS System (December 2, 2021)
  • 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)
  • 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)

FDA data resources