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K Number
K133178
Device Name
LUXATOR LX HANDPIECE
Manufacturer
DIRECTA AB
Date Cleared
2015-11-24

(768 days)

Product Code
EGS
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

This device is designed to expand the tooth socket by widening the gap between root and bone to facilitate tooth removal due to caries, trauma, orthodontic reasons.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information regarding the acceptance criteria of a medical device's performance, nor does it describe a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a dental handpiece, Luxator LX.

It primarily discusses:

  • The FDA's determination of substantial equivalence for the device.
  • General regulatory requirements for marketing the device.
  • Contact information for FDA resources.
  • The indications for use of the Luxator LX handpiece.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth methods based on the given text.

§ 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.