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510(k) K130180

CLEANSER ROOT CANAL by Cerkamed Wojciech Pawlowski — Product Code KJJ

K130180 is an FDA 510(k) premarket notification submitted by Cerkamed Wojciech Pawlowski for the device "CLEANSER ROOT CANAL". The FDA issued a decision of Substantially Equivalent on October 3, 2013. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2013
Date Received
January 25, 2013
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