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510(k) K123538

EPIEN ROOT CANAL CLEANSER by Epien Medical, Inc. — Product Code KJJ

K123538 is an FDA 510(k) premarket notification submitted by Epien Medical, Inc. for the device "EPIEN ROOT CANAL CLEANSER". The FDA issued a decision of Substantially Equivalent on February 1, 2013. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Epien Medical, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2013
Date Received
November 16, 2012
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 Epien Medical, Inc.

  • K201785 — EPIEN Dental Cleanser (September 9, 2021)

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