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K Number
K241187

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Device Name
Alien Aligners
Manufacturer
Alien Milling Technologies
Date Cleared
2024-07-26

(88 days)

Product Code
NXC
Regulation Number
872.5470
Type
Traditional
Panel
Dental
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 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.