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K Number
K042905
Device Name
NEO-CLIP ORTHODONTIC BRACKET ACCESSORY
Manufacturer
DENTSPLY INTL.
Date Cleared
2004-11-04

(14 days)

Product Code
NJM
Regulation Number
872.5470
Type
Special
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.