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K Number
K073045
Device Name
SAPPHIRE CERAMIC BRACKET
Manufacturer
ORTHO TECHNOLOGY, INC
Date Cleared
2007-12-18

(50 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
Device Description
AI/ML Overview

§ 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.