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K Number
K160410
Device Name
WOlf High Speed Handpieces - Medium head, WOlf High Speed Handpieces - Small head
Manufacturer
Dental Savings Club
Date Cleared
2016-09-29

(226 days)

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

WOlf High Speed Handpieces are used intra-orally by trained dental professionals for drilling and preparation of dental cavities for restoration, such as fillings.

Device Description

WOlf High Speed Handpieces

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a dental handpiece. It does not contain any information regarding acceptance criteria, performance studies, or clinical validation data for the WOlf High Speed Handpieces.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided document. The document primarily focuses on:

  • The FDA's determination of substantial equivalence.
  • Regulatory requirements for the device.
  • Indications for Use.

§ 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.