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K Number
K070663
Device Name
A-DEC/W&H SYNEA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TA-98, TA-97, A-DEC/W&H SYNEA HANDPIECE ATTACHMENT
Manufacturer
A-DEC, INC.
Date Cleared
2007-07-05

(118 days)

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

The A-dec/W&H Synea Air-Driven Highspeed Handpiece is an air-powered dental handpiece for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

The A-dec/W&H Synea Handpiece Attachment is powered by either an air-motor or electric micromotor for use in general dentistry. This device is designed for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth.

Device Description

Not Found

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) clearance letter for the A-dec/W&H Synea dental handpieces does not contain any information regarding acceptance criteria, device performance studies, or the methodologies typically associated with evaluating AI/ML-based medical devices.

This document is a standard clearance letter for a conventional medical device (dental handpieces) and primarily focuses on:

  • Substantial Equivalence Determination: Confirming that the device is substantially equivalent to a legally marketed predicate device.
  • Regulatory Classification: Stating the regulation number, name, and regulatory class.
  • Indications for Use: Describing how the device is intended to be used.
  • Compliance Guidance: Reminding the applicant of general controls and other FDA regulations.

Therefore, I cannot extract the information required by your request, such as a table of acceptance criteria, sample sizes, expert qualifications, or details about AI/ML study methodologies, because that information is not present in 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.