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FDA 510(k)

EMPOWER CLEAR

K-Number: K122753 · 2012-12-14

ApplicantAmerican Orthodontics
Decision Date2012-12-14
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EMPOWER CLEAR is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics. It received FDA 510(k) clearance on 2012-12-14 under 510(k) number K122753. 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 EMPOWER CLEAR?

EMPOWER CLEAR is a medical device that received FDA 510(k) clearance on 2012-12-14. The listed applicant is American Orthodontics. The 510(k) number is K122753.

When did EMPOWER CLEAR receive FDA 510(k) clearance?

EMPOWER CLEAR received FDA 510(k) clearance on 2012-12-14, under 510(k) number K122753.

Who is the listed applicant for EMPOWER CLEAR?

The FDA 510(k) record lists American Orthodontics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMPOWER CLEAR?

The FDA product code for EMPOWER CLEAR is NJM.

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Other records listing American Orthodontics as applicant

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.

K261840BracePaste Prime PlusK232011CleoK202276BracePaste Band and Build LCK181910BracePaste MTP Light Cure PrimerK172953Acid EtchantK160782BracePaste Adhesive

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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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