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Nubrace Invisible Removable Orthodontics

by Nubrace, Inc.

510(k) K073121

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 NumberK073121 Date12 Feb 2009ClearedStatusActive

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  • Withdrawn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

Overview

AI-generated summary, 27 Sep 2026

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

Nubrace Invisible Removable Orthodontics is a sequential aligner device used for dental applications. It is classified as a Class II medical device and has been determined to be substantially equivalent to a predicate device through the FDA 510(k) clearance process.

The device is supplied as a removable orthodontic aligner system designed for minor to moderate teeth correction. It is intended for use in dental settings under the supervision of a dental provider, who inserts the aligners over the patient's top and bottom teeth after production. The device is reusable across the treatment course as part of a sequential series, with no indication of sterility, single-use designation, MRI safety, or specific storage conditions provided in the data.

Questions

AI-generated answers, 27 Sep 2026

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

  • What is Nubrace Invisible Removable Orthodontics used for?

    Nubrace Invisible Removable Orthodontics is a sequential aligner device intended for minor to moderate teeth correction in dental applications, designed to be worn over the top and bottom teeth under the supervision of a dental provider as part of a treatment series.

  • How is Nubrace Invisible Removable Orthodontics supplied and is it reusable?

    The device is supplied as a removable orthodontic aligner system in a sequential series, and it is reusable across the treatment course as patients progress through each aligner in the series, with no single-use designation indicated.

  • Does Nubrace Invisible Removable Orthodontics require sterilization or have special storage conditions?

    The device data provides no indication of sterility requirements, single-use designation, or specific storage conditions; it is intended for reuse during the treatment sequence as supplied by the manufacturer.