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K Number
K030163
Device Name
ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925
Manufacturer
ASEPTICO, INC.
Date Cleared
2003-03-03

(46 days)

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

Aseptico's AEU-925 VCT can be used for a wide range of dental procedures including;

  1. Dental endodontic surgeries, such as drilling into the root canal.

  2. General dentistry, such as removing carious material from the dentine.

  3. Performing dental implant surgeries, such as perforating the bone, and tapping and threading procedures required before placement of implant prosthetics.

Device Description

This programmable dental system digitally controls the speed, direction and torque of a low voltage dental motor. Each dental system has programmed into memory a library of speed and torque settings for commonly used Endodontic files and dental implants. The AEU-925 can also be programmed by the dentist to hold in memory six speed and torque settings that they prefer to use most. The speed and torque limiting features are intended to reduce overtightening of Endodontic files and dental implants.

List of features:

    1. Stores speed and torque settings in its "Library" that can be recalled later
    1. Allows the operator to select the "mode" of operation from either "Implant" or "Endodontic" operation.
    1. Has a built in dynamometer to calibrate the handbiece, motor and console prior to use.
    1. Uses the autoclavable motor AE-9A-30.
    1. Has a built in water pump to provide irrigation
    1. Allows connectivity to a personal computer to upload new settings,
    1. Foot control AE-19 can be used to activate water on/off, change forward/reverse direction of the drill, scroll through various presets that are in the program menu,
    1. Allows the operator to use voice commands to step through library of preset speed and torque values.
AI/ML Overview

The provided document is a 510(k) summary for a dental handpiece and accessories device (Aseptico VCT Versatile Control Technology Model AEU-925). It describes the device's features, intended use, and indicates its substantial equivalence to previously marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert involvement, ground truth establishment, or any of the other specific details requested in your prompt regarding device performance and validation.

The 510(k) summary is a regulatory document to establish substantial equivalence for market clearance, not typically a detailed report on a device's performance validation against specific acceptance criteria.

Therefore, I cannot populate the table or answer your questions based on the provided text. The document states that the device "digitally controls the speed, direction and torque of a low voltage dental motor" and has "speed and torque limiting features intended to reduce overtightening of Endodontic files and dental implants," but it does not provide any quantitative data or studies to prove these claims against specific metrics.

§ 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.