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510(k) K141352

ENDOCYN ROOT CANAL IRRIGATION SOLUTION by Oculus Innovative Sciences — Product Code KJJ

K141352 is an FDA 510(k) premarket notification submitted by Oculus Innovative Sciences for the device "ENDOCYN ROOT CANAL IRRIGATION SOLUTION". The FDA issued a decision of Substantially Equivalent on August 18, 2014. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Oculus Innovative Sciences has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2014
Date Received
May 23, 2014
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 Oculus Innovative Sciences

  • K162217 — LOYON (March 23, 2017)
  • K161034 — Microcyn Plus Wound Care Solution (August 19, 2016)
  • K153648 — Microcyn Plus Skin and Wound Hydrogel (April 19, 2016)
  • K152945 — Alevicyn SG Antipruritic Gel (December 15, 2015)
  • K152055 — Ceramax Skin Barrier Cream (November 23, 2015)
  • K143590 — Alevicyn SG Antipruritic Gel (June 4, 2015)
  • K141012 — HYDROCLEANSE WOUND CARE SOLUTION (August 8, 2014)
  • K131672 — MICROCYN SCAR MANAGEMENT HYDROGEL (November 15, 2013)
  • K102945 — PEDIACYN ATOPIC DERMATITIS HYDROGEL (February 2, 2011)
  • K093585 — MICROCYN SKIN AND WOUND HYDROGEL (March 8, 2010)

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