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510(k) K201785

EPIEN Dental Cleanser by Epien Medical, Inc. — Product Code KJJ

K201785 is an FDA 510(k) premarket notification submitted by Epien Medical, Inc. for the device "EPIEN Dental Cleanser". The FDA issued a decision of Substantially Equivalent on September 9, 2021. 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
September 9, 2021
Date Received
June 30, 2020
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.

  • K123538 — EPIEN ROOT CANAL CLEANSER (February 1, 2013)

Other clearances for product code KJJ

  • K250279 — RC-SwiftPrep (July 2, 2025)
  • K241354 — Sealer Solvent (August 27, 2024)
  • 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