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510(k) K153528

PacEndo EDTA by Pac-Dent International, Inc. — Product Code KJJ

K153528 is an FDA 510(k) premarket notification submitted by Pac-Dent International, Inc. for the device "PacEndo EDTA". The FDA issued a decision of Substantially Equivalent on February 1, 2016. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Pac-Dent International, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2016
Date Received
December 9, 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

Other clearances by Pac-Dent International, Inc.

  • K162662 — GingiDent Gingival Retraction Paste (October 20, 2017)
  • K160577 — PacEndo Chlorhexidine (July 25, 2016)
  • K151123 — Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film (March 3, 2016)
  • K151852 — PacEndo Sodium Hyprochlorite (November 10, 2015)
  • K151150 — Elements (July 28, 2015)
  • K141717 — PACSEAL PIT & FISSURE SEALANT (March 9, 2015)
  • K141422 — PROFLUORO FLUORIDE VARNISH (September 30, 2014)
  • K130672 — OPTIFLOW II FLOWABLE COMPOSITE, LC (August 13, 2013)

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