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Avex CX2 and Avex CXI2 Ceramic Brackets

by Opal Orthodontics by Ultradent Products, Inc.

510(k) K113334

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113334 Date3 Feb 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NJM
Device Class
Class II
Regulation
21 CFR Part 872.5470
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Avex CX2 and Avex CXi2 Ceramic Brackets are orthodontic ceramic brackets designed for bonding to teeth to facilitate controlled tooth movement during orthodontic treatment. Constructed from polycrystalline alumina, these brackets feature tie-wing undercuts for ligature placement and a water-soluble color-coded dot for tooth identification, ensuring precise alignment and tracking during therapy.

These brackets are supplied as single-use, non-sterile devices intended for dental office use. They are classified as Class II medical devices under FDA regulations (872.5470) and have received FDA 510(k) clearance (K113334) as substantially equivalent to a predicate device. Each bracket is individually packaged for clinical use, with no additional sterilization required prior to application.

Other devices from Opal Orthodontics by Ultradent Products

  • Avex CX2

    Class II

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are the Avex CX2 and CXi2 Ceramic Brackets designed for?

    The Avex CX2 and CXi2 Ceramic Brackets are orthodontic devices specifically designed to bond to teeth and facilitate controlled tooth movement during orthodontic treatment. Their construction from polycrystalline alumina ensures durability, while the tie-wing undercuts allow for secure ligature placement, aiding in precise alignment and tracking throughout therapy.

  • How are these brackets supplied and intended for use?

    These brackets are supplied as single-use, non-sterile devices, individually packaged for clinical use in dental offices. No additional sterilization is required prior to application, as they are intended for one-time use per patient.

  • Are the Avex CX2 and CXi2 Ceramic Brackets reusable?

    No, these brackets are explicitly designed for single-use only. Each bracket is individually packaged to ensure sterility and safety for one application per patient, preventing cross-contamination and maintaining clinical standards.

  • What distinguishes the Avex CX2 and CXi2 Ceramic Brackets from other orthodontic brackets?

    The Avex CX2 and CXi2 Ceramic Brackets feature tie-wing undercuts for secure ligature placement and a water-soluble color-coded dot for easy tooth identification. These design elements, combined with their polycrystalline alumina material, enhance precision and tracking during orthodontic treatment, setting them apart from standard brackets.

  • How should these brackets be stored before use?

    The brackets should be stored in their original, unopened individual packaging to maintain sterility and prevent contamination. Keep them in a clean, dry environment away from direct sunlight or extreme temperatures, as recommended for single-use medical devices.