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K Number
K061689
Device Name
AQUATINE EC ENDODONTIC CLEANSER
Manufacturer
PURICORE, INC.
Date Cleared
2006-08-24

(70 days)

Product Code
KJJ
Regulation Number
N/A
Type
Traditional
Panel
DE
Reference & Predicate Devices
K962743,K992919,K053167
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Aquatine™ EC Endodontic Cleanser is intended to irrigate, cleanse and debride root canal systems.

Device Description

Aquatine™ EC Endodontic Cleanser irrigates, cleanses and debrides. The mechanical action of the solution moving in the root canal facilitates easy removal of debris and necrotic pulp tissue from the root canal.

AI/ML Overview

The Aquatine™ EC Endodontic Cleanser is deemed substantially equivalent based on non-clinical performance and biocompatibility data. The provided document, K061689, does not contain information about specific acceptance criteria or a study with detailed performance metrics, sample sizes, expert involvement, or comparative effectiveness studies that would be typical for an AI/ML powered device. Instead, the clearance is based on the device's similarity in function and intended use to existing legally marketed predicate devices and the fact that all components of Aquatine™ EC have been used in legally marketed devices.

Therefore, I cannot populate the table or answer the specific questions as the information is not present in the provided text. The document is a 510(k) summary and clearance letter for a non-AI/ML medical device, which explains why these details are absent.

N/A