FDA 510(k)

Clear21

K-Number: K192202 · 2019-11-12

ApplicantWorld Class Technology Corporation

Decision Date2019-11-12

Product CodeNJM

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Clear21 is the device name listed in this FDA 510(k) record. The listed applicant is World Class Technology Corporation. It received FDA 510(k) clearance on 2019-11-12 under 510(k) number K192202. 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 Clear21?

Clear21 is a medical device that received FDA 510(k) clearance on 2019-11-12. The listed applicant is World Class Technology Corporation. The 510(k) number is K192202.

When did Clear21 receive FDA 510(k) clearance?

Clear21 received FDA 510(k) clearance on 2019-11-12, under 510(k) number K192202.

Who is the listed applicant for Clear21?

The FDA 510(k) record lists World Class Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clear21?

The FDA product code for Clear21 is NJM.

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 Orthodontics K232011CleoAmerican Orthodontics K231635A-Line AdvancedBiocetec Co., Ltd.K230225DynaFlex Clear Brackets & ButtonsDyna Flex K222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos Medicos K222764LightForce Orthodontic SystemLightforce Orthodontics

Official Source

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