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FDA 510(k)

DynaFlex Clear Brackets & Buttons

K-Number: K230225 · 2023-06-05

ApplicantDyna Flex
Decision Date2023-06-05
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DynaFlex Clear Brackets & Buttons is the device name listed in this FDA 510(k) record. The listed applicant is Dyna Flex. It received FDA 510(k) clearance on 2023-06-05 under 510(k) number K230225. 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 DynaFlex Clear Brackets & Buttons?

DynaFlex Clear Brackets & Buttons is a medical device that received FDA 510(k) clearance on 2023-06-05. The listed applicant is Dyna Flex. The 510(k) number is K230225.

When did DynaFlex Clear Brackets & Buttons receive FDA 510(k) clearance?

DynaFlex Clear Brackets & Buttons received FDA 510(k) clearance on 2023-06-05, under 510(k) number K230225.

Who is the listed applicant for DynaFlex Clear Brackets & Buttons?

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

What is the FDA product code for DynaFlex Clear Brackets & Buttons?

The FDA product code for DynaFlex Clear Brackets & Buttons is NJM.

Other records listing Dyna Flex 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.

K190583DynaFlex

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.K222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos MedicosK222764LightForce Orthodontic SystemLightforce OrthodonticsK220689Vatech ClismileRayence Co., Ltd.

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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