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K Number
K062305
Device Name
CLARITY MODIFIED CERAMIC BRACKETS
Manufacturer
3M UNITEK
Date Cleared
2006-10-18

(71 days)

Product Code
NJM
Regulation Number
872.5470
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Clarity Modified Ceramic Bracket is intended for use in orthodontic treatment.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain any information regarding the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device named "Clarity™ Modified Ceramic Brackets," which primarily discusses regulatory aspects and substantial equivalence to legally marketed predicate devices. It does not include details about device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot provide the requested information in the table format.

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.