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FDA 510(k)

AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS

K-Number: K113334 · 2012-02-03

ApplicantOpal Orthodontics by Ultradent Products, Inc.
Decision Date2012-02-03
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS is the device name listed in this FDA 510(k) record. The listed applicant is Opal Orthodontics by Ultradent Products, Inc.. It received FDA 510(k) clearance on 2012-02-03 under 510(k) number K113334. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS?

AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS is a medical device that received FDA 510(k) clearance on 2012-02-03. The listed applicant is Opal Orthodontics by Ultradent Products, Inc.. The 510(k) number is K113334.

When did AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS receive FDA 510(k) clearance?

AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS received FDA 510(k) clearance on 2012-02-03, under 510(k) number K113334.

Who is the listed applicant for AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS?

The FDA 510(k) record lists Opal Orthodontics by Ultradent Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS?

The FDA product code for AVEX CX2 AND AVEX CXI2 CERAMIC BRACKETS is NJM.

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Related Devices (Code: NJM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232827LightForce Orthodontic SystemLightforce OrthodonticsK232011CleoAmerican OrthodonticsK231635A-Line AdvancedBiocetec Co., Ltd.K230225DynaFlex Clear Brackets & ButtonsDyna FlexK222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos MedicosK222764LightForce Orthodontic SystemLightforce Orthodontics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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