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K Number
K960260
Device Name
STAR TITAN SERIES MOTORS & ATTACHMENTS
Manufacturer
DENTALEZ GROUP
Date Cleared
1996-03-28

(70 days)

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

Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures.

Device Description

Air powered low speed dental motor that powers various dental attachments and accessories to facilitate procedure by the dental clinician during routine dental procedures.

AI/ML Overview

This document is a 510(k) summary for dental low-speed motors and attachments from Star Dental, submitted in 1996. It does not contain the type of acceptance criteria, study details, performance metrics, or ground truth information that your request is asking for.

The document focuses on demonstrating substantial equivalence to existing predicate devices based on:

  • Similar materials: "Materials used to manufacture the components are similar."
  • Identical means of operation: "Means of operation are identical, compressed air powers a variable speed rotary vane motor to provide power for various dental procedures."
  • Virtually identical performance specifications: "The performance specifications are virtually identical."
  • Minor differentiations: "The differentiation between the predicate device and the submitted one is more precise speed control, spring pre-loaded bearings."

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) from the provided text because it describes a clearance process for a mechanical dental device based on substantial equivalence, not a diagnostic AI/ML device that would undergo the types of studies you've outlined.

§ 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.