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K Number
K042178
Device Name
ORTHODONTIC CERAMIC BRACKETS
Manufacturer
DENTSPLY INTL.
Date Cleared
2004-08-30

(19 days)

Product Code
NJM
Regulation Number
872.5470
Type
Special
Panel
DE
Reference & Predicate Devices
K852179
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

Device Description

The ORTHODONTIC CERAMIC BRACKETS are bonded to teeth to apply pressure to the tooth, transmitted through a flexible orthodontic wire, to alter the tooth position. The dimpled, beveled bracket base includes rhomboid and "torque-in-the-base" features. The modified ceramic, orthodontic brackets have indented walls and are available with or without glass coating in the wire slot. The modified brackets are more transparent than the predicate device.

AI/ML Overview

The provided text is a 510(k) summary for Orthodontic Ceramic Brackets. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/medical device study with performance metrics like sensitivity, specificity, or AUC.

This document describes a traditional medical device (orthodontic brackets) and its substantial equivalence to a predicate device based on material, design, and intended use, rather than a data-driven performance study. Therefore, the requested information elements related to AI model evaluation are not applicable or present in this document.

To be specific:

  1. A table of acceptance criteria and the reported device performance: Not applicable. The document discusses "technological characteristics" and states "The function and performance of the modified brackets is very similar to the predicate." No quantifiable performance metrics are provided.
  2. Sample size used for the test set and the data provenance: Not applicable. There is no test set in the context of an AI performance evaluation.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not an AI diagnostic/prognostic device being evaluated.
  4. Adjudication method: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
  6. If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used: Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on demonstrating that the new orthodontic ceramic brackets are substantially equivalent to previously marketed devices (predicate device K852179) by highlighting minor design changes (dimpled, beveled base, rhomboid and "torque-in-the-base" features, indented walls, optional glass coating, and increased transparency) without changes to the intended use or fundamental scientific technology. All materials used are stated to have been in legally marketed DENTSPLY devices.

§ 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.