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K Number
K111249
Device Name
ORTHOSLENDERIZER
Manufacturer
ORTHOMATICS, INC.
Date Cleared
2012-02-08

(281 days)

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

The OrthoSlenderizer is intended for use as a method of achieving interproximal enamel reduction of teeth using a reciprocal movement.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a device called "OrthoSlenderizer." It primarily addresses regulatory approval and does not contain information on acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on:

  • Device Name: OrthoSlenderizer
  • Regulation Number/Name: 21 CFR 872.4200, Dental Handpiece and Accessories
  • Regulatory Class: I
  • Product Code: EFB
  • FDA Determination: Substantially equivalent to legally marketed predicate devices.
  • Intended Use: "as a method of achieving interproximal enamel reduction of teeth using a reciprocal movement."

To answer your questions, I would need a different document, such as a summary of safety and effectiveness (SSE) or the actual study report submitted with the 510(k) application.

§ 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.