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510(k) K201785

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

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)

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  • 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)