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K Number
K983413
Device Name
MODEL MS-1 HANDPIECE
Manufacturer
PARKELL, INC.
Date Cleared
1998-12-21

(84 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

An electrically-powered, low-speed (

Device Description

The MODEL MS-1 HANDPIECE is an electrically-powered, lowspeed handpiece intended for use with a contra-angle in which a rubber cup or bristle brush is inserted for the purpose of cleaning and/or polishing teeth using an appropriate prophylaxis paste, pumice/water mixture, or the like.

AI/ML Overview

This document describes a 510(k) submission for a dental handpiece, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML-specific metrics cannot be extracted from the provided text.

The document primarily focuses on:

  • Device Identification: Trade Name (MODEL MS-1 HANDPIECE), Common Name (Low-Speed Prophy Handpiece), Classification Name (Dental Handpiece).
  • Intended Use: An electrically-powered, low-speed handpiece for cleaning and polishing teeth with a contra-angle, rubber cup/bristle brush, and prophylaxis paste.
  • Equivalence: Listing of predicate devices, implying a substantial equivalence pathway for clearance rather than a novel technology requiring extensive performance studies.
  • Regulatory Clearance: A letter from the FDA indicating that the device has been found substantially equivalent to legally marketed predicate devices.

There is no mention of:

  • Acceptance criteria in terms of analytical or clinical performance metrics.
  • Specific studies proving performance against such criteria.
  • Sample sizes, data provenance, ground truth establishment, expert involvement, or AI/ML-specific study designs (like MRMC or standalone performance).

§ 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.