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K Number
K052271
Device Name
RINSENDO
Manufacturer
AIR TECHNIQUES, INC.
Date Cleared
2006-05-26

(280 days)

Product Code
NYL
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The RinsEndo is used for root canal irrigation/ disinfection.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "RinsEndo". This document confirms that the device is substantially equivalent to a legally marketed predicate device for its indicated use (root canal irrigation/disinfection) and allows it to be marketed.

However, the document does NOT contain any information regarding:

  • Acceptance criteria for the device's performance.
  • The specifics of any study performed to prove the device meets acceptance criteria.
  • Device performance results.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number or qualifications of experts for ground truth.
  • Adjudication methods.
  • MRMC comparative effectiveness study details or effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • How ground truth for training was established.

This 510(k) letter is an administrative document about market clearance, not a technical report detailing the performance evaluation studies. Therefore, I cannot extract the requested information from the provided text.

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.