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510(k) K053167

BIOPURE MTAD ROOT CANAL CLEANSER by Dentsply Intl., Inc. — Product Code KJJ

K053167 is an FDA 510(k) premarket notification submitted by Dentsply Intl., Inc. for the device "BIOPURE MTAD ROOT CANAL CLEANSER". The FDA issued a decision of Substantially Equivalent on Dec 8, 2005. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Dentsply Intl., Inc. has 290 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 8, 2005
Date Received
Nov 14, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Root Canal
Device Class
Class U
Review Panel
DE
Submission Type
510(k)

Other clearances by Dentsply Intl., Inc.

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  • K123615 — IRIS - HIGH STRENGTH GLASS CERAMIC (Feb 22, 2013)
  • K103244 — QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION (Feb 14, 2011)
  • K093221 — PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II (Oct 30, 2009)
  • K083805 — ANKYLOS C/X DENTAL IMPLANT SYSTEM (May 22, 2009)
  • K082198 — DURASHIELD PLUS (Oct 29, 2008)
  • K072730 — FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS (Mar 27, 2008)
  • K072989 — AXIS SYSTEM (Jan 28, 2008)
  • K073117 — DENTIN DESENSITIZER AGENT (Dec 19, 2007)

Other clearances for product code KJJ

  • K250279 — RC-SwiftPrep (Jul 2, 2025)
  • K241354 — Sealer Solvent (Aug 27, 2024)
  • K201785 — EPIEN Dental Cleanser (Sep 9, 2021)
  • K211813 — Triton (Aug 18, 2021)
  • K193357 — V-Mix (Oct 23, 2020)
  • K193409 — Vista Rinse, Vista Rinse Plus (Sep 9, 2020)
  • K200330 — RC-Prime Root Canal Preparation Cream (Jul 6, 2020)
  • K173163 — ChlorCid, ChlorCid V, ChlorCid Surf (Feb 9, 2018)
  • K162311 — Straumann PrefGel (Mar 7, 2017)
  • K160577 — PacEndo Chlorhexidine (Jul 25, 2016)

FDA data resources