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K Number
K182999
Device Name
General Cutting Contra Handpiece
Manufacturer
Nakanishi Inc.
Date Cleared
2019-04-16

(168 days)

Product Code
EGS
Regulation Number
872.4200
Type
Traditional
Panel
DE
Reference & Predicate Devices
K113655,K073652,K972569
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials and removal of crowns and filling materials.

Device Description

The General Cutting Contra Handpiece features an allowable maximum motor speed at 40,000 min-1 . The handpieces are provided optic and non-optic and are designed with a contra-angle appearance. Models are available to be connected directly onto motors compliant to ISO 3964. Available handpieces include the S-Max M Contra Series, Ti-Max X Contra Series, Ti-Max Z Contra Series and the Ti-Max nano Series.

AI/ML Overview

The provided text describes a dental handpiece and does not contain information about an AI/ML device. Therefore, I cannot extract acceptance criteria or study details relevant to an AI/ML device from this document.

The document discusses:

  • Device Name: General Cutting Contra Handpiece (a dental instrument)
  • Manufacturer: NAKANISHI INC.
  • Intended Use: Cutting and grinding teeth, cavity preparations, etc., in general dentistry.
  • Regulatory Classification: Class I
  • Bench Testing: Conformance to technical standards, internal specifications, and FDA guidance documents related to dental handpieces (e.g., sterilization, biocompatibility, electrical safety).
  • Substantial Equivalence: Claimed based on similarities to predicate dental handpieces in intended use, operation principles, design, and medical use.

Since this is not an AI/ML device, the requested information regarding AI/ML-specific acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML does not apply to this document.

§ 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.