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FDA 510(k)

CLARITY MODIFIED CERAMIC BRACKETS

K-Number: K062305 · 2006-10-18

Applicant3M Unitek
Decision Date2006-10-18
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CLARITY MODIFIED CERAMIC BRACKETS is the device name listed in this FDA 510(k) record. The listed applicant is 3M Unitek. It received FDA 510(k) clearance on 2006-10-18 under 510(k) number K062305. 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 CLARITY MODIFIED CERAMIC BRACKETS?

CLARITY MODIFIED CERAMIC BRACKETS is a medical device that received FDA 510(k) clearance on 2006-10-18. The listed applicant is 3M Unitek. The 510(k) number is K062305.

When did CLARITY MODIFIED CERAMIC BRACKETS receive FDA 510(k) clearance?

CLARITY MODIFIED CERAMIC BRACKETS received FDA 510(k) clearance on 2006-10-18, under 510(k) number K062305.

Who is the listed applicant for CLARITY MODIFIED CERAMIC BRACKETS?

The FDA 510(k) record lists 3M Unitek as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLARITY MODIFIED CERAMIC BRACKETS?

The FDA product code for CLARITY MODIFIED CERAMIC BRACKETS is NJM.

Related Clinical Trials

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.

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Other records listing 3M Unitek 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.

K100536TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVEK073697TRANSBOND SUPREME ADHESIVEK020394APC PLUS ADHESIVEK014142UNITE BONDING ADHESIVEK950514TRI-CURE GLASS IONOMER ORTHODONTIC BAND CEMENT

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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