FDA 510(k)

K Clear

K-Number: K220726 · 2022-03-16

Decision Date2022-03-16

Product CodeNXC

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

K Clear is the device name listed in this FDA 510(k) record. The listed applicant is Kline Europe GmbH. It received FDA 510(k) clearance on 2022-03-16 under 510(k) number K220726. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K Clear?

K Clear is a medical device that received FDA 510(k) clearance on 2022-03-16. The listed applicant is Kline Europe GmbH. The 510(k) number is K220726.

When did K Clear receive FDA 510(k) clearance?

K Clear received FDA 510(k) clearance on 2022-03-16, under 510(k) number K220726.

Who is the listed applicant for K Clear?

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

What is the FDA product code for K Clear?

The FDA product code for K Clear is NXC.

Related Devices (Code: NXC)

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.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) Limited K250739Primeprint Direct AlignerDreve Dentamid GmbH

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.