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510(k) K150020

Irritrol, EDS Combo-Rinse by Essential Dental Systesm, Inc. — Product Code KJJ

K150020 is an FDA 510(k) premarket notification submitted by Essential Dental Systesm, Inc. for the device "Irritrol, EDS Combo-Rinse". The FDA issued a decision of Substantially Equivalent on February 25, 2015. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 2015
Date Received
January 6, 2015
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

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  • 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