LogoFDA 510(k) Search
K Number
K052714
Device Name
RAVE COMPOSITE BRACKET
Manufacturer
FDA AGENTS
Date Cleared
2005-10-26

(27 days)

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

Indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth. The devices are for Orthodontic Use Only, on the order of an Orthodontist.

Device Description

Rave Composite Bracket

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device (Rave Composite Bracket) and does not contain the specific information requested about acceptance criteria and study details.

The letter confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It outlines regulatory requirements but does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication method for a test set.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
  6. Results of a standalone algorithm-only performance study.
  7. Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is primarily regulatory approval, not a scientific study report.

§ 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.