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3M™ Clarity™Aligners with Quick Attachments

by 3M Company, Unitek Orthodontic Products

510(k) K233257

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233257 Date29 Sep 2023ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0743-2025 FDA Class II initiated 22 Nov 2024

    Attachments may not mate with the tooth as intended in the digital treatment design.

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  • Withdrawn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
NXC
Device Class
Class II
Regulation
21 CFR Part 872.5470
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a Sequential Aligner, a removable orthodontic appliance designed to gradually reposition teeth to correct malocclusions. The aligners are made of clear plastic and incorporate Quick Attachments—small, removable attachments—to enhance retention and optimize force distribution for precise tooth movement during treatment.

Clarity Aligners with Quick Attachments are supplied as a single-use, non-sterile system for dental office use. They are classified as Class II under FDA regulations (21 CFR 872.5470) and received FDA 510(k) clearance (K233257) as substantially equivalent to predicate devices. The system includes multiple aligner sets, each tailored to sequential stages of tooth alignment, and is intended for use under the supervision of a licensed orthodontist.

Other devices from 3M Company, Unitek Orthodontic Products

Questions

AI-generated answers, 19 Sep 2026

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

  • Are the 3M™ Clarity™ Aligners with Quick Attachments designed for single-use or can they be reused?

    The 3M™ Clarity™ Aligners with Quick Attachments are explicitly supplied as a single-use system for dental office use. This means each aligner set is intended for one patient and should not be reused, as reuse could compromise patient safety and treatment efficacy.

  • What is the sterility status of the 3M™ Clarity™ Aligners with Quick Attachments, and how should they be handled in the dental office?

    The device is non-sterile, meaning it is not intended for use in sterile procedures or on open wounds. Since it is designed for dental office use, it should be handled in a clean environment, but sterilization is not required before patient application. Always follow manufacturer guidelines for proper storage and handling to maintain hygiene.

  • How are the aligners customized for different stages of tooth alignment, and are there multiple sizes or models available?

    The system includes multiple aligner sets, each tailored to sequential stages of tooth alignment to gradually reposition teeth. While the exact sizes or models aren’t specified in the data, the aligners are designed to fit individual patients’ dental arches and progress through treatment phases. Customization is likely handled through digital scanning and orthodontic planning, not through a fixed set of pre-sized models.

  • What is the regulatory pathway for the 3M™ Clarity™ Aligners with Quick Attachments, and how does this affect their use in clinical practice?

    The device received FDA 510(k) clearance (K233257) as substantially equivalent to predicate devices, confirming its compliance with U.S. regulations. This clearance indicates it meets FDA standards for safety and effectiveness as a Class II medical device under 21 CFR 872.5470. Clinically, this means the aligners can be legally marketed and used in the U.S. under the supervision of a licensed orthodontist, as specified in the description.

  • Are the Quick Attachments included in the aligner system reusable or disposable, and how do they impact treatment?

    The Quick Attachments are described as small, removable components designed to enhance retention and optimize force distribution during tooth movement. While the data does not explicitly state their reuse status, the aligners themselves are single-use, implying the attachments are likely intended for one-time use per aligner set to maintain precision and hygiene. Their purpose is to improve treatment accuracy by providing consistent points of contact for tooth alignment.