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K Number
K973800
Device Name
23:1 REDUCTION ANGLE
Manufacturer
MIDWEST DENTAL PRODUCTS CORP.
Date Cleared
1998-03-11

(156 days)

Product Code
EGS,DAT
Regulation Number
872.4200
Type
Traditional
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Indications for Use of this device is to provide a dental professional a lowspeed handpiece which may be used, in conjunction with various dental burs as identified by the dental professional, in the performance of various dental procedures including, but not limited to, Prophy, Post and Pin Drilling, Pin Setting, Root Canal Enlargement and Sealing, and Caries Removal. The intended patient population is the general population requiring such procedures.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA regarding a dental handpiece, specifically the 23:1 Reduction Angle. The letter confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does not contain any information regarding acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC studies. The document is a regulatory approval letter, not a study report.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or details about a study proving the device meets the criteria based solely on the provided text.

The information present in the document is:

  • Device: 23:1 Reduction Angle (Dental Handpiece)
  • Applicant: Midwest Dental Products
  • FDA K Number: K973800
  • Regulatory Class: I
  • EGS Product Code: EGS
  • Indications for Use: To provide a dental professional a low-speed handpiece for various dental procedures including, but not limited to, Prophy, Post and Pin Drilling, Pin Setting, Root Canal Enlargement and Sealing, and Caries Removal for the general patient population.
  • Decision: Substantially equivalent.

§ 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.