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K Number
K981433
Device Name
ORTHODONTIC BRACES
Manufacturer
MIDWEST ORTHODONTIC MFG.
Date Cleared
1998-06-25

(66 days)

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

BRACKET IS TO BE TEMPORARILY BONDED TO THE TOOTH BRACKET IS TO BE TEMPORARTET BORDED TO THE TEETH.

Device Description

PLASTIC BRACKET - ORTHODONTIC

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for "Orthodontic Braces," specifically a "PLASTIC BRACKET - ORTHODONTIC." It confirms that the device is substantially equivalent to legally marketed devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth methodology, or comparative effectiveness with AI assistance.

The document is purely a regulatory clearance notice. To answer your request, I would need additional information which is not present in the provided text.

§ 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.