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K Number
K032361
Device Name
ENDOPURE ROOT CANAL CLEANSER
Manufacturer
DENTSPLY INTL.
Date Cleared
2004-01-12

(165 days)

Product Code
KJJ
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
K003422
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Used to chemically clean and disinfect a root canal system after endodontic instrumentation

Device Description

EndoPurc™ Root Canal Cleanser is a two-part liquid/powder formulation. The mixed solution cleanses the root canal, removes the smear layer, and kills the bactcria in an instrumented root canal without harming the tooth structure or soft tissue.

The EndoPure™ Root Canal Cleanser is easily dispensed using a disposable syringe.

AI/ML Overview

This document is a 510(k) summary for DENTSPLY International's EndoPure™ Root Canal Cleanser. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

The provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics.

The document primarily focuses on:

  • Device Description: EndoPure™ Root Canal Cleanser is a two-part liquid/powder formulation intended to clean and disinfect root canals, remove the smear layer, and kill bacteria.
  • Intended Use: To chemically clean and disinfect a root canal system after endodontic instrumentation.
  • Technological Characteristics: All components have been used in legally marketed devices. The product was evaluated for cytotoxicity and mutagenicity and found to be non-cytotoxic and non-mutagenic.
  • Predicate Device: EDTA Root Canal Cleanser K003422.
  • FDA Clearance: The FDA found the device substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert numbers, adjudication, MRMC, standalone performance), or ground truth establishment based on the provided text.

The document states, "We believe that the prior use of the components of EndoPurc™ Root Canal Cleanser in Iegally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of FindoPure™ Root Canal Cleanser for the indicated uses." However, the actual "performance data provided" is not detailed in this 510(k) summary. This summary is a high-level overview, and the specific study details would typically be in the full 510(k) submission, which is not provided here.

N/A