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K Number
K053055
Device Name
ORTHODONTIC POLYMER COMPOSITE BRACKET
Manufacturer
GESTENCO INTERNATIONAL AB
Date Cleared
2005-12-22

(52 days)

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

Orthodontic Polymer Composite Bracket is intended to be bonded on teeth to aid in the movement of patient's teeth during orthodontic treatment.

Device Description

Orthodontic Polymer Composite Bracket

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding an Orthodontic Polymer Composite Bracket. It primarily addresses regulatory approval based on substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria, as this information is not present in the provided document.

§ 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.